Measures for the Administration of Drug Registration

（Promulgated by Order No. 27 of the State Administration for Market Regulation on January 22, 2020, effective from July 1, 2020）

CHAPTER I GENERAL PROVISIONS

　　Article 1 In order to standardize drug registration and ensure the safety, effectiveness, and controllable quality of drugs, in accordance with the Drug Administration Law of the People's Republic of China (hereinafter referred to as the "Drug Administration Law"), the Chinese Medicine Law of the People's Republic of China, the Vaccine Administration Law of the People's Republic of China (hereinafter referred to as the "Vaccine Administration Law"), the Administrative Licensing Law of the People's Republic of China These measures are formulated in accordance with laws and administrative regulations such as the Implementation Regulations of the Drug Administration Law of the People's Republic of China.

　　Article 2 These Measures shall apply to drug development, registration, and supervision and management activities conducted within the territory of the People's Republic of China for the purpose of drug listing.

　　Article 3 Drug registration refers to the activity where the applicant for drug registration (hereinafter referred to as the applicant) submits applications and supplementary applications for drug clinical trials, drug marketing licenses, and re registration in accordance with legal procedures and relevant requirements. The drug regulatory department conducts safety, effectiveness, and quality controllability reviews based on laws, regulations, and existing scientific knowledge, and decides whether to agree to their application.

　　After obtaining the drug registration certificate, the applicant becomes the holder of the drug marketing license (hereinafter referred to as the holder).

　　Article 4 Drug registration is classified and managed according to traditional Chinese medicine, chemical drugs, and biological products.

　　Traditional Chinese medicine registration is classified according to innovative traditional Chinese medicine, improved new traditional Chinese medicine, ancient classic and famous traditional Chinese medicine compound preparations, and the same name and formula medicine.

　　Chemical drug registration is classified according to chemical drug innovation drugs, chemical drug improved new drugs, generic drugs, etc.

　　The registration of biological products is classified according to innovative drugs for biological products, improved new drugs for biological products, and marketed biological products (including biologically similar drugs).

　　The detailed classification and corresponding application requirements for drugs such as traditional Chinese medicine, chemical drugs, and biological products shall be organized and formulated by the National Drug Administration based on the product characteristics, innovation level, and evaluation management needs of registered drugs, and shall be announced to the public.

　　The registration application for drugs produced overseas shall be executed in accordance with the detailed classification of drugs and the corresponding application requirements.

　　Article 5 The National Drug Administration is in charge of the national drug registration management work, responsible for establishing a drug registration management system and systems, formulating drug registration management standards, organizing drug registration review and approval in accordance with the law, and related supervision and management work. The Drug Evaluation Center of the State Drug Administration (hereinafter referred to as the Drug Evaluation Center) is responsible for the review of drug clinical trial applications, drug marketing license applications, supplementary applications, and overseas production drug re registration applications. China Institute for the Control of Food and Drug Products (hereinafter referred to as the Chinese Academy of Inspection and Quarantine), the National Pharmacopoeia Commission (hereinafter referred to as the Pharmacopoeia Commission), the Food and Drug Audit and Inspection Center of the National Drug Administration (hereinafter referred to as the Drug Verification Center), the Drug Evaluation Center of the National Drug Administration (hereinafter referred to as the Drug Evaluation Center), the Administrative Matters Acceptance Service and Complaint Reporting Center of the National Drug Administration The Information Center of the National Drug Administration (hereinafter referred to as the Information Center) and other pharmaceutical professional and technical institutions are responsible for the drug registration inspection, universal name approval, verification, monitoring and evaluation, certification and delivery, as well as corresponding information construction and management required for the implementation of drug registration management in accordance with the law.

　　Article 6 The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government are responsible for the management of drug registration related to the following drugs within their respective administrative regions:

（1） Acceptance, review, and approval of re registration applications for domestically produced drugs;

（2） Management of registration and reporting matters related to changes in drug marketing;

（3） Organize the daily supervision of non clinical safety evaluation research institutions and clinical trial institutions for drugs, as well as the investigation and punishment of illegal behaviors;

（4） Participate in drug registration verification and inspection organized by the National Drug Administration;

（5） Matters related to drug registration commissioned by the National Drug Administration.

Drug professional technical institutions established or designated by the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government shall undertake the review, inspection, verification, monitoring, and evaluation work required for the implementation of drug supervision and management in accordance with the law.

　　Article 7 Drug registration management follows the principles of openness, fairness, and impartiality, guided by clinical value, encourages research and creation of new drugs, and actively promotes the development of generic drugs.

　　The National Drug Administration continues to promote the reform of the review and approval system, optimize the review and approval procedures, improve the efficiency of review and approval, and establish a drug registration management system led by review, supported by inspection, verification, monitoring, and evaluation.

Chapter 2 Basic System and Requirements

　　Article 8 Engaging in drug development and drug registration activities shall comply with relevant laws, regulations, rules, standards and norms; If other evaluation methods and techniques are used in accordance with relevant technical guidelines, their scientific and applicability should be demonstrated; We should ensure the authenticity, accuracy, completeness, and traceability of the entire process information.

　　Drugs should comply with the national drug standards and the drug quality standards approved by the National Drug Administration. The drug quality standards approved by the National Drug Administration are the drug registration standards. The drug registration standards shall comply with the general technical requirements of the Pharmacopoeia of the People's Republic of China and shall not be lower than the provisions of the Pharmacopoeia of the People's Republic of China. If the testing items or indicators of the registered variety are not applicable to the Pharmacopoeia of the People's Republic of China, the applicant shall provide sufficient supporting data.

　　Professional technical institutions such as drug evaluation centers should formulate technical guidance principles and procedures based on scientific progress, industry development reality, and the needs of drug supervision and management work, and disclose them to the society.

　　Article 9 The applicant should be an enterprise or drug development institution that can bear corresponding legal responsibilities. Overseas applicants should designate corporate entities within China to handle relevant drug registration matters.

　　Article 10 Applicants should complete relevant research work in pharmacy, pharmacology, toxicology, and drug clinical trials before applying for drug registration on the market. Research on non clinical safety evaluation of drugs should be conducted in institutions certified by non clinical drug research quality management practices, and comply with non clinical drug research quality management practices. Clinical trials of drugs should be approved, and bioequivalence trials should be recorded; Drug clinical trials should be conducted in drug clinical trial institutions that comply with relevant regulations and comply with quality management standards for drug clinical trials.

　　When applying for drug registration, truthful, sufficient, and reliable data, materials, and samples should be provided to prove the safety, effectiveness, and quality controllability of the drug.

　　If overseas research materials and data are used to support drug registration, their sources, research institutions or laboratory conditions, quality system requirements, and other management conditions should comply with the principles of the International Coordinating Committee on Technical Requirements for Drug Registration for Human Use, and comply with the relevant requirements of drug registration management in China.

　　Article 11 If the original drug registration approval document and its attachments are changed, the applicant shall conduct sufficient research and verification of the drug change in accordance with regulations and relevant technical guidelines, fully evaluate the potential impact of the change on drug safety, effectiveness, and quality controllability, and submit supplementary applications, records, or reports in accordance with the change procedures.

　　Article 12 The validity period of the drug registration certificate is five years. During the validity period of the drug registration certificate, the holder shall continue to ensure the safety, effectiveness, and quality controllability of the marketed drug, and apply for drug re registration six months before the expiration of the validity period.

　　Article 13 The National Drug Administration has established an accelerated drug registration system to support clinical value oriented drug innovation. For eligible drug registration applications, applicants can apply for breakthrough treatment drugs, conditional approval, priority review approval, and special approval procedures. In the process of drug development and registration, the drug supervision and management department and its professional technical institutions provide necessary technical guidance, communication and exchange, prioritize resource allocation, shorten review time, and other policies and technical support.

　　Article 14 The National Drug Administration has established a review and approval system for the association of chemical raw materials, excipients, and packaging materials and containers that come into direct contact with drugs. When approving drug formulations, the chemical raw materials are reviewed and approved together, and the relevant excipients, packaging materials and containers that come into direct contact with the drugs are reviewed and approved together. The Drug Evaluation Center shall establish a registration platform for the information of chemical raw materials, excipients, and packaging materials and containers that come into direct contact with drugs. The relevant registration information shall be publicly available for selection by relevant applicants or holders, and shall be associated for evaluation during the registration application review of relevant drug formulations.

　　Article 15 Prescription drugs and over-the-counter drugs are subject to classified registration and conversion management. The Drug Evaluation Center formulates technical guidelines and procedures for the registration of over-the-counter drugs based on their characteristics, and makes them publicly available. The Drug Evaluation Center formulates technical requirements and procedures for the conversion of prescription and over-the-counter drugs after their launch, and makes them publicly available.

　　Article 16 Applicants can communicate and exchange major issues with professional technical institutions such as the Drug Evaluation Center during key stages such as before the application for drug clinical trials, during the drug clinical trial process, and before the application for drug marketing licenses. During the drug registration process, professional technical institutions such as the Drug Evaluation Center can organize communication and exchange with applicants according to work needs.

　　沟通交流的程序、要求和时限，由药品审评中心等专业技术机构依照职能分别制定，并向社会公布。

　　Article 17 Professional technical institutions such as the Drug Evaluation Center shall establish an expert consultation system and an expert consultation committee according to work needs. They shall listen to expert opinions on major issues during the review, verification, inspection, and approval of common names, and fully utilize the technical support role of experts.

　　Article 18 The National Drug Administration shall establish a catalog of chemical drugs that have been newly approved for listing and have passed the quality and efficacy consistency evaluation of generic drugs, including drug names, active ingredients, dosage forms, specifications, whether they are reference preparations, holders, and other relevant information. The catalog shall be updated in a timely manner and made public to the public. The procedures and requirements for the collection of chemical drug catalogs shall be formulated by the Drug Evaluation Center and made public to the public.

　　Article 19 The National Drug Administration supports the inheritance and innovation of traditional Chinese medicine, establishes and improves a registration management system and technical evaluation system that conforms to the characteristics of traditional Chinese medicine, encourages the use of modern scientific technology and traditional research methods to develop traditional Chinese medicine, strengthens quality control of traditional Chinese medicine, and improves the level of clinical trials of traditional Chinese medicine.

　　In the application for registration of traditional Chinese medicine, the applicant should conduct a clinical value and resource evaluation, highlighting the clinical value orientation and promoting sustainable utilization of resources.

Chapter 3 Drug Listing Registration

Section 1 Clinical Trials of Drugs

　　Article 20 The drug clinical trials referred to in these Measures refer to drug research conducted in the human body for the purpose of drug registration and marketing, in order to determine the safety and effectiveness of drugs.

　　Article 21 Clinical trials of drugs are divided into phase I clinical trials, phase II clinical trials, phase III clinical trials, phase IV clinical trials, and bioequivalence trials. According to the characteristics and research objectives of the drug, the research content includes clinical pharmacology research, exploratory clinical trials, confirmatory clinical trials, and post market research.

　　Article 22 Clinical trials of drugs should be conducted in drug clinical trial institutions that meet the corresponding conditions and are registered according to regulations. Among them, clinical trials of vaccines should be carried out or organized by tertiary medical institutions or disease prevention and control institutions at or above the provincial level that meet the conditions specified by the National Drug Administration and the National Health Commission.

　　Article 23 After completing the pharmaceutical, pharmacological, and toxicological studies supporting drug clinical trials, the applicant shall submit relevant research materials in accordance with the requirements of the application materials. If the application materials meet the requirements after formal examination, they will be accepted. The Drug Evaluation Center shall organize pharmaceutical, medical, and other technical personnel to review accepted drug clinical trial applications. The application for clinical trials of drugs shall be decided within 60 days from the date of acceptance, and the applicant shall be notified of the approval results through the website of the Drug Evaluation Center; If no notice is given within the deadline, it shall be deemed as consent, and the applicant may conduct clinical trials of drugs according to the submitted plan.

　　The applicant who is approved to conduct drug clinical trials is the drug clinical trial applicant (hereinafter referred to as the applicant).

　　Article 24 If the applicant intends to conduct bioequivalence tests, they shall complete the bioequivalence test filing on the website of the Drug Evaluation Center as required, and carry out relevant research work according to the filing plan.

　　Article 25 Conducting clinical trials of drugs should be reviewed and approved by the ethics committee.

　  The management of drugs used in clinical trials should comply with the relevant requirements of the Good Clinical Practice for Drug Trial Quality Management.

　　Article 26 If approved to conduct drug clinical trials, the applicant shall develop a corresponding drug clinical trial plan before conducting subsequent phased drug clinical trials, which shall be reviewed and approved by the ethics committee before proceeding. The corresponding drug clinical trial plan and supporting materials shall be submitted on the website of the Drug Evaluation Center.

　　Article 27 If a drug approved for clinical trials intends to increase indications (or functional indications) or increase the use of drugs in combination with other drugs, the applicant shall submit a new drug clinical trial application, and only after approval can new drug clinical trials be conducted.

　　If a drug approved for marketing needs to undergo clinical trials for additional indications (or functional indications), a new drug clinical trial application should be submitted.

　　Article 28 Applicants should regularly submit safety update reports during the research and development period on the website of the Drug Evaluation Center. The safety update report during the research and development period should be submitted once a year, within two months after each year of drug clinical trial approval. The Drug Evaluation Center may request applicants to adjust the reporting cycle based on the review situation.

　　For suspicious and unexpected serious adverse reactions and other potential serious safety risk information that occur during drug clinical trials, the applicant shall promptly report to the Drug Evaluation Center in accordance with relevant requirements. According to the severity of safety risks, applicants can be required to take measures to strengthen risk control, such as adjusting the drug clinical trial protocol, informed consent form, and researcher manual. If necessary, applicants can be required to suspend or terminate the drug clinical trial.

　　The specific requirements for safety update reports during the research and development period shall be formulated and announced by the Drug Evaluation Center.

　　Article 29 During the clinical trial of drugs, if there are changes in the clinical trial protocol, non clinical or pharmaceutical changes, or new discoveries, the applicant shall fully evaluate the impact on the safety of the subjects in accordance with regulations and relevant technical guidelines.

　　If the applicant evaluates that it does not affect the safety of the subjects, it can be directly implemented and reported in the safety update report during the research and development period. If it may increase the safety risk of the subject, a supplementary application should be submitted. A decision on whether to agree to a supplementary application shall be made within 60 days from the date of acceptance, and the applicant shall be notified of the approval result through the website of the Drug Evaluation Center; If no notice is given within the time limit, it shall be deemed as consent.

　　If there is a change in the applicant, the changed applicant shall bear the relevant responsibilities and obligations of the drug clinical trial.

　　Article 30 During the clinical trial of drugs, if safety issues or other risks are found, the applicant shall promptly adjust the clinical trial plan, suspend or terminate the clinical trial, and report to the Drug Evaluation Center.

　　Under any of the following circumstances, the applicant may be required to adjust the drug clinical trial plan, suspend or terminate the drug clinical trial:

　　（1） The ethics committee fails to fulfill its duties;

　　（2） Unable to effectively ensure the safety of the subjects;

　　（3） The applicant fails to submit a safety update report during the research and development period as required;

　　（4） The applicant fails to handle and report suspicious and unexpected serious adverse reactions in a timely manner;

　　（5） There is evidence to prove that the research drug is ineffective;

　　（6） There are quality issues with drugs used in clinical trials;

　　（7） Falsification and falsification during drug clinical trials;

　　（8） Other situations that violate the quality management standards of drug clinical trials.

　　When there are large-scale and unexpected serious adverse reactions in drug clinical trials, or there is evidence to prove that there are serious quality issues with the drugs used in clinical trials, the sponsor and drug clinical trial institution shall immediately stop the drug clinical trial. The drug regulatory department may, in accordance with its responsibilities, order the adjustment of clinical trial plans, suspension or termination of drug clinical trials.

　　Article 31 After a drug clinical trial is ordered to be suspended, if the applicant intends to continue the drug clinical trial, they shall submit a supplementary application for resuming the drug clinical trial after completing the rectification. The drug clinical trial can only be continued after the review and approval. If the clinical trial of a drug has been suspended for at least three years and has not been applied for and approved to resume the drug clinical trial, the drug clinical trial license shall automatically become invalid.

　　After the termination of drug clinical trials, if it is planned to continue drug clinical trials, a new application for drug clinical trials should be submitted.

　　Article 32 Clinical trials of drugs should be conducted within three years after approval. If no subject signs an informed consent form within three years from the date of approval for a drug clinical trial application, the drug clinical trial license shall automatically become invalid. If clinical trials of drugs still need to be conducted, a new application should be made.

　　Article 33 Applicants should register drug clinical trial plans and other information on the drug clinical trial registration and information disclosure platform before conducting drug clinical trials. During the clinical trial of drugs, the applicant shall continuously update the registration information and register the results of the drug clinical trial after the end of the drug clinical trial. The registration information is publicly available on the platform, and the applicant is responsible for the authenticity of the drug clinical trial registration information.

　　The specific requirements for drug clinical trial registration and information disclosure shall be formulated and announced by the Drug Evaluation Center.

Section 2 Drug Marketing License

　　Article 34 After completing research on pharmacy, pharmacology, toxicology, and clinical trials to support drug registration, determining quality standards, completing commercial scale production process validation, and preparing for drug registration verification and inspection, the applicant applies for a drug marketing license and submits relevant research materials in accordance with the requirements of the application materials. After formal examination of the application materials, if they meet the requirements, they will be accepted.

　　Article 35 For generic drugs, in vitro diagnostic reagents under drug management, and other eligible situations, if the applicant evaluates that it is not necessary or impossible to conduct drug clinical trials and meets the conditions for exempted drug clinical trials, the applicant may directly apply for a drug marketing license. The technical guidelines and specific requirements for exempting clinical trials of drugs shall be formulated and announced by the Drug Evaluation Center.

　　Generic drugs should have the same quality and efficacy as the reference formulation. The applicant should refer to relevant technical guidelines to select a reasonable reference formulation.

　　Article 36 Those who meet one of the following conditions can directly apply for OTC drug marketing license:

（1） Drugs that have the same active ingredients, indications (or functional indications), dosage forms, and specifications as over-the-counter drugs listed in China;

（2） Non prescription drugs that have been determined by the National Drug Administration to change their dosage form or specifications, but do not change their indications (or functional indications), dosage, or route of administration;

（3） A new compound formulation composed of the active ingredients of over-the-counter drugs determined by the National Drug Administration;

（4） Other situations where OTC drug marketing licenses are directly applied for.

　　Article 37 If the generic name of the drug intended for use in the application is not listed in the national drug standards or drug registration standards, the applicant shall submit an application for approval of the generic name at the same time as submitting the drug marketing license application. After the acceptance of the drug marketing license application, the relevant information for the approval of the generic name shall be forwarded to the Pharmacopoeia Commission, which shall provide feedback to the Drug Evaluation Center after approval.

　　The generic name of the drug to be used in the application for drugs has been included in the national drug standards or drug registration standards. If the Drug Evaluation Center deems it necessary to approve the generic name of the drug during the evaluation process, it shall notify the Pharmacopoeia Commission to approve the generic name and provide relevant information. After approval by the Pharmacopoeia Commission, it shall be reported back to the Drug Evaluation Center.

　　When approving the generic name of a drug, the Pharmacopoeia Commission shall communicate and communicate with the applicant, and inform the applicant of the approval result.

　　Article 38 The Drug Evaluation Center shall organize pharmaceutical, medical, and other technical personnel to review the accepted drug marketing license applications as required.

　　During the review process, drug registration verification and inspection should be initiated based on risks, and relevant technical institutions should complete the verification and inspection work within the specified time limit.

　　The Drug Evaluation Center shall conduct a comprehensive evaluation of the safety, effectiveness, and quality controllability of drugs based on drug registration application materials, verification results, and inspection results. Non prescription drugs shall also be transferred to the Drug Evaluation Center for suitability review.

　　Article 39 If the comprehensive evaluation conclusion is passed, the drug is approved for marketing and a drug registration certificate is issued. If the comprehensive review conclusion is not approved, a decision shall be made not to approve it. The drug registration certificate contains information such as the drug approval number, holder, and production enterprise. The drug registration certificate for non prescription drugs should also indicate the category of non prescription drugs.

　　The approved drug production process, quality standards, instructions, and labels shall be sent to the applicant as attachments to the drug registration certificate, and if necessary, the requirements for post market research of the drug shall also be attached. The above information will be included in the drug variety file and updated in a timely manner based on changes made after listing.

　　After the drug is approved for marketing, the holder shall produce the drug in accordance with the production process and quality standards approved by the National Drug Administration, and refine and implement it in accordance with the requirements of drug production quality management standards.

　　Article 40 During the review period of drug marketing license application, if there are significant changes that may affect the safety, effectiveness, and quality controllability of the drug, the applicant shall withdraw the original registration application, conduct supplementary research, and reapply.

　　If the applicant's name changes or registered address changes do not involve technical evaluation content, they shall promptly notify the Drug Evaluation Center in writing and submit relevant supporting materials.

Section 3 Related Review and Approval

　　Article 41 The Drug Evaluation Center conducts a related review of the chemical raw materials, excipients, and packaging materials and containers directly in contact with drugs used in drug formulation registration applications.

　　Manufacturers of packaging materials and containers for chemical raw materials, excipients, and direct contact drugs shall register product information and research materials on the registration platform for packaging materials and containers for chemical raw materials, excipients, and direct contact drugs in accordance with the requirements of the related review and approval system. The Drug Evaluation Center shall publicly disclose basic information such as registration number, product name, enterprise name, and production address to the society for the selection of drug formulation registration applicants.

　　Article 42 Applicants for pharmaceutical preparations can apply for drug registration by directly selecting registered chemical raw materials, excipients, and packaging materials and containers that come into direct contact with the drug; For the selection of unregistered chemical raw materials, excipients, and packaging materials and containers that come into direct contact with drugs, relevant research materials should be reported together with the drug formulation registration application.

　　Article 43 When reviewing the registration application for pharmaceutical preparations, the Drug Evaluation Center conducts a related review of the chemical raw materials, excipients, and packaging materials and containers directly in contact with drugs used in pharmaceutical preparations. If additional information is required, the applicant for pharmaceutical preparations or the registration enterprise for chemical raw materials, excipients, and packaging materials and containers directly in contact with drugs shall be required to provide additional information in accordance with the supplementary information procedure. Based on the risk, the applicant for pharmaceutical preparations or the registration enterprise for chemical raw materials, excipients, and packaging materials and containers directly in contact with drugs may propose to Auxiliary materials and packaging materials and containers that come into direct contact with drugs shall undergo extended inspections by enterprises.

　　Those who imitate the chemical raw materials used in domestic marketed drugs can apply for separate review and approval.

　　Article 44 For chemical raw materials, excipients, and packaging materials and containers that come into direct contact with drugs that have been reviewed and approved separately, the Drug Evaluation Center shall update the registration status identification on the registration platform for chemical raw materials, excipients, and packaging materials and containers that come into direct contact with drugs, and disclose relevant information to the society. Among them, a chemical raw material approval notice, as well as the approved production process, quality standards, and labels, shall be issued simultaneously to the chemical raw material. The registration number shall be specified in the chemical raw material approval notice; If approval is not granted, a notice of disapproval for chemical raw materials shall be issued.

　　The registration status of chemical raw materials, excipients, and packaging materials and container products that come into direct contact with drugs that have not been approved through associated review will remain unchanged, and the application for related drug formulations will not be approved.

Section 4 Drug Registration Verification

　　Article 45 Drug registration verification refers to the verification activities conducted on the research and production site to verify the authenticity, consistency, and commercial production conditions of the application materials, as well as the compliance and data reliability of drug development. It also refers to the necessary inspections conducted on the chemical raw materials, excipients, and packaging materials and containers directly in contact with drugs involved in drug registration applications Extension inspection activities conducted by suppliers or other entrusted institutions.

　　The principles, procedures, time limits, and requirements for the initiation of drug registration verification shall be formulated and announced by the Drug Evaluation Center; The principles, procedures, time limits, and requirements for the implementation of drug registration verification shall be formulated and announced by the Drug Verification Center.

　　Article 46 The Drug Evaluation Center determines whether to conduct on-site verification of drug registration and development based on risk, based on the level of drug innovation and the previous verification status of drug research institutions.

　　If the Drug Review Center decides to initiate on-site verification of drug registration and development, it shall notify the Drug Review Center to organize and implement the verification during the review period, and inform the applicant at the same time. The drug inspection center shall complete on-site inspections within the prescribed time limit and provide relevant materials such as inspection results and conclusions to the drug evaluation center for comprehensive evaluation.

　　Article 47 The Drug Evaluation Center determines whether to initiate on-site verification of drug registration based on factors such as the variety, process, facilities, and previous verification status applied for registration, based on risks.

　　For innovative drugs, improved new drugs, and biological products, on-site verification of drug registration and production, as well as pre market inspection of drug production quality management standards, should be carried out.

　　For generic drugs, based on whether the corresponding production scope drug production license has been obtained and the same dosage form variety is already on the market, on-site verification of drug registration and production, as well as inspection of pre market drug production quality management standards, will be conducted based on risks.

　　Article 48 After the acceptance of a drug registration application, the Drug Evaluation Center shall conduct a preliminary review within forty days after acceptance. If on-site verification of drug registration and production is required, the Drug Verification Center shall be notified to organize the verification, provide relevant materials required for the verification, and inform the applicant and the drug regulatory department of the province, autonomous region, or municipality where the applicant or production enterprise is located. In principle, the Drug Verification Center should complete the verification work 40 days before the expiration of the review deadline, and provide feedback on the verification situation, results, and other relevant materials to the Drug Evaluation Center.

　　If a pre market inspection of drug production quality management standards is required, the Drug Verification Center shall coordinate with the relevant drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government to implement the inspection simultaneously with the on-site inspection of drug registration and production. The management requirements for the pre market inspection of drug production quality management standards shall be implemented in accordance with the relevant provisions of the Drug Production Supervision and Management Measures.

　　The applicant shall undergo verification within the prescribed time limit.

　　Article 49 During the review process, if the Drug Evaluation Center discovers doubts about the authenticity of the application materials or clear clues for reporting, which require on-site inspection and verification, it shall initiate a causal inspection and conduct sampling inspection if necessary.

　　Article 50 When applying for a drug marketing license, the applicant and the production enterprise should have obtained the corresponding drug production license.

Section 5 Drug Registration Inspection

　　Article 51 Drug registration inspection, including standard review and sample inspection. Standard review refers to the laboratory evaluation of the scientificity of the items set in the applicant's application for drug standards, the feasibility of testing methods, and the rationality of quality control indicators. Sample inspection refers to laboratory testing of samples in accordance with the drug quality standards declared by the applicant or approved by the drug evaluation center.

　　The principles, procedures, and time limits for the initiation of drug registration inspection shall be formulated and announced by the Drug Evaluation Center. Before accepting the application for drug registration, the specific work procedures and requirements for drug registration inspection, as well as the technical requirements and specifications for drug registration inspection, shall be formulated and announced by the Chinese Academy of Inspection and Quarantine.

　　Article 52 If the inspection items and methods used for the same variety of drugs included in the national drug standards are consistent, no standard review can be conducted and only sample inspection can be conducted. In other cases, standard review and sample inspection should be conducted.

　　Article 53 The Chinese People's Procuratorate or a drug inspection institution designated by the State Administration for Drug Administration shall undertake the following drug registration inspections:

（1） Innovative drugs;

（2） Improved new drugs (excluding traditional Chinese medicine);

（3） Biological products, radioactive drugs, and in vitro diagnostic reagents under drug management;

（4） Other drugs specified by the National Drug Administration.

　　The drug registration inspection of drugs produced overseas shall be carried out by the port drug inspection agency organized by the Chinese Academy of Inspection and Quarantine.

　　The registration inspection of other drugs shall be undertaken by the provincial-level drug inspection institution where the applicant or production enterprise is located.

　　Article 54 After completing pharmaceutical related research to support drug listing, determining quality standards, and completing commercial scale production process validation, the applicant may submit a drug registration inspection to the Chinese People's Procuratorate or the drug regulatory department of a province, autonomous region, or municipality directly under the central government before accepting the drug registration application; If the applicant fails to submit a drug registration inspection before the acceptance of the drug registration application, the drug registration inspection shall be initiated by the Drug Evaluation Center within forty days after the acceptance of the drug registration application. In principle, the applicant can only submit a drug registration inspection once before accepting the drug registration application, and cannot simultaneously submit a drug registration inspection to multiple drug inspection institutions.

　　The drug registration and inspection materials submitted by the applicant shall be consistent with the corresponding content of the drug registration application materials, and shall not change the drug inspection agency, samples, and materials during the drug registration and inspection process.

　　Article 55 For the registration application of domestically produced drugs, if the applicant submits a drug registration inspection before the acceptance of the drug registration application, they shall apply for sampling to the relevant drug supervision and management departments of provinces, autonomous regions, and municipalities directly under the Central Government. The drug supervision and management departments of provinces, autonomous regions, and municipalities directly under the Central Government shall organize sampling and seal it. The applicant shall send the sampling form, samples, inspection required materials, and reference materials to the corresponding drug inspection institution.

　　For the registration application of drugs produced overseas, if the applicant submits a drug registration inspection before the acceptance of the drug registration application, the applicant shall take samples according to the prescribed requirements and send the samples, inspection required materials, and reference materials to the Chinese Academy of Inspection.

　　Article 56 If the registration application for domestically produced drugs requires drug registration inspection after acceptance, the Drug Evaluation Center shall issue a drug registration inspection notice to the drug inspection institution and the applicant within forty days after acceptance. The applicant shall apply for sampling to the relevant drug supervision and management departments of provinces, autonomous regions, and municipalities directly under the central government. The drug supervision and management departments of provinces, autonomous regions, and municipalities directly under the central government shall organize sampling and seal it. The applicant shall submit the sampling form, samples, inspection required materials, and reference materials to the corresponding drug inspection institution within the specified time limit.

　　For the registration application of drugs produced overseas, if drug registration inspection is required after the acceptance of the application, the applicant shall take samples according to the prescribed requirements and send the samples, inspection required materials, and reference materials to the Chinese Academy of Inspection.

　　Article 57 The drug inspection institution shall review the inspection samples and materials submitted by the applicant within five days, make a decision on whether to accept them, and inform the drug evaluation center at the same time. If corrections are needed, the applicant should be notified at once.

　　In principle, drug inspection institutions should provide standard review opinions and inspection reports to the drug evaluation center 40 days before the expiration of the evaluation deadline.

　　Article 58 

In the process of drug review and verification, if it is found that the authenticity of the application materials is questionable or there are clear clues to report, or if it is deemed necessary to conduct sample inspection, samples can be taken for sample inspection.

During the review process, the drug review center can propose a single review of quality standards based on risks.

Chapter 4 Accelerated Market Registration Procedures for Drugs

Section 1 Breakthrough Treatment Drug Program

　　Article 59 During the clinical trial of drugs, if there are innovative drugs or modified drugs used to prevent and treat diseases that seriously endanger life or affect quality of life, and there is no effective prevention and treatment method or sufficient evidence to demonstrate significant clinical advantages compared to existing treatment methods, the applicant may apply for breakthrough treatment drug procedures.

　　Article 60 If applying for the application of breakthrough treatment drug procedures, the applicant shall submit an application to the Drug Evaluation Center. Those that meet the conditions will be included in the breakthrough treatment drug program after being publicly announced by the drug evaluation center according to the procedure.

　　Article 61 Provide the following policy support for clinical trials of drugs included in breakthrough treatment drug programs:

　　（1） Applicants can submit communication and exchange requests to the Drug Evaluation Center during the critical stages of drug clinical trials, and the Drug Evaluation Center arranges reviewers for communication and exchange;

　　（2） Applicants can submit phased research materials to the Drug Evaluation Center, which will provide opinions or suggestions on the next research plan based on existing research materials and provide feedback to the applicant.

　　Article 62 For clinical trials of drugs included in the breakthrough treatment drug program, if the applicant discovers that they no longer meet the inclusion criteria, they should promptly request the termination of the breakthrough treatment drug program to the drug evaluation center. If the drug evaluation center finds that it no longer meets the inclusion criteria, it shall promptly terminate the breakthrough treatment drug program for that variety and notify the applicant.

Section 2 Conditional Approval Procedure

　　Article 63 During the clinical trial of drugs, drugs that meet the following conditions can apply for conditional approval:

　　（1） Drugs used to treat diseases that pose a serious threat to life and have no effective treatment methods. Clinical trials of drugs have confirmed their efficacy and can predict their clinical value;

　　（2） Drugs urgently needed in public health, with clinical trial data showing efficacy and being able to predict their clinical value;

　　（3） Vaccines urgently needed to respond to major public health emergencies or other vaccines deemed urgently needed by the National Health Commission, with benefits greater than risks assessed.

　　Article 64 If applying for conditional approval, the applicant shall communicate and exchange with the Drug Evaluation Center regarding the conditions for conditional approval for listing and the research work to be completed after listing. After confirmation through communication and exchange, the applicant shall submit an application for drug listing license.

　　After evaluation, if it meets the requirements for conditional approval, the drug registration certificate shall specify the validity period of the conditional approval drug registration certificate, the research work that needs to be completed after being launched, and the completion time limit.

　　Article 65 During the review process, if it is found that the drug registration application included in the conditional approval procedure cannot meet the conditional approval conditions, the drug evaluation center shall terminate the conditional approval procedure for the variety and inform the applicant to study the application according to normal procedures.

　　Article 66 For conditionally approved drugs, the holder shall take corresponding risk management measures after the drug is launched, and complete relevant studies such as drug clinical trials within the prescribed period, and apply for them in the form of supplementary applications.

　　If further research is required upon approval of the vaccine registration application, the vaccine holder shall complete the research within the prescribed period.

　　Article 67 If the holder of a conditionally approved drug fails to complete the research as required or cannot prove that the benefits outweigh the risks, the National Drug Administration shall handle it in accordance with the law until the drug registration certificate is cancelled.

Section 3 Priority Review and Approval Procedure

　　Article 68 When applying for a drug marketing license, the following drugs with obvious clinical value can apply for priority review and approval procedures:

（1） Shortage of drugs urgently needed in clinical practice, innovative drugs for the prevention and treatment of major infectious diseases and rare diseases, and improved new drugs;

（2） New varieties, dosage forms, and specifications of children's drugs that meet the physiological characteristics of children;

（3） Urgent vaccines and innovative vaccines for disease prevention and control;

（4） Drugs included in the breakthrough treatment drug program;

（5） Drugs that meet the conditions for approval;

（6） Other situations where the State Administration for Drug Administration stipulates priority review and approval.

　　Article 69 Before submitting an application for drug marketing license, the applicant shall communicate and communicate with the Drug Evaluation Center. After confirmation through communication and communication, the applicant shall submit a priority review and approval application to the Drug Evaluation Center at the same time as submitting the application for drug marketing license. Those that meet the conditions shall be included in the priority review and approval process by the Drug Evaluation Center after being publicized in accordance with the procedures.

　　Article 70 For drug marketing license applications included in the priority review and approval process, the following policy support will be provided:

（1） The review deadline for drug marketing license applications is 130 days;

（2） The review deadline for rare disease drugs that are urgently needed for clinical use and have been listed overseas but not yet listed domestically is 70 days;

（3） Priority shall be given to the verification, inspection, and approval of drug generic names;

（4） After communication and confirmation, additional technical materials can be submitted.

　　Article 71 During the review process, if it is found that the drug registration application included in the priority review and approval procedure cannot meet the conditions for priority review and approval, the drug review center shall terminate the priority review and approval procedure for the variety, conduct the review according to the normal review procedure, and inform the applicant.

Section 4 Special Approval Procedures

　　Article 72 When there is a threat of a public health emergency and after the occurrence of a public health emergency, the National Drug Administration may, in accordance with the law, decide to implement special approval for the prevention and control drugs required for emergency public health emergencies.

　　Article 73 For drug registration applications that require special approval, the National Drug Administration shall organize and accelerate the acceptance, review, verification, and inspection of drug registration in accordance with the principles of unified command, early intervention, fast and efficient, and scientific approval. The situation, procedures, time limits, requirements, etc. of special approval shall be implemented in accordance with the provisions of the drug special approval procedure.

　　Article 74 For drugs included in the special approval process, their use can be limited within a certain period and scope according to the specific needs of disease prevention and control.

　　Article 75 For drugs included in the special approval process, if it is found that they no longer meet the inclusion criteria, the special approval process for the drug shall be terminated and the applicant shall be notified.

Chapter 5 Changes and Re registration of Drugs after Marketing

Section 1 Postmarket Research and Changes of Drugs

　　Article 76 Holders should actively conduct post market research on drugs, further confirm the safety, effectiveness, and quality controllability of drugs, and strengthen the continuous management of marketed drugs.

　　If the drug registration certificate and its attachments require the holder to carry out relevant research work after the drug is launched, the holder shall complete it within the prescribed time limit and submit supplementary applications, records or reports as required.

After the drug is approved for marketing, the holder shall continue to conduct research on the safety and effectiveness of the drug, timely record or submit supplementary applications for revising the instructions based on relevant data, and continuously update and improve the instructions and labels. The drug regulatory department may, in accordance with its responsibilities, require holders to revise the instructions and labels based on the results of adverse drug reaction monitoring and post market evaluation of drugs.

　　Article 77 The changes after the drug is launched are classified and managed according to their risks and impact on the safety, effectiveness, and quality controllability of the drug. They are divided into approval type changes, filing type changes, and reporting type changes.

　　Holders shall comprehensively evaluate and verify the impact of changes on drug safety, effectiveness, and quality controllability in accordance with relevant regulations and technical guidelines, and conduct corresponding research work.

　　The technical guidelines for changes in research after drug marketing shall be formulated by the Drug Evaluation Center and announced to the public.

　　Article 78 The following changes shall be declared by the holder through supplementary application and implemented after approval:

（1） Major changes in the drug production process;

（2） Changes to the effectiveness content and other content that increases safety risks in the drug instructions;

（3） The holder transfers the drug marketing license;

（4） Other changes that require approval as stipulated by the National Drug Administration.

　　Article 79 The following changes shall be reported by the holder to the drug regulatory department of the province, autonomous region, or municipality directly under the central government for filing before the implementation of the changes:

　　（

1） Moderate changes in the drug production process;

（2） Changes in the content of drug packaging labels;

（3） Drug packaging;

（4） Other changes that require filing as stipulated by the National Drug Administration.

　　If the above-mentioned changes occur to drugs produced overseas, they shall be reported to the Drug Evaluation Center for filing before the implementation of the changes.

　　The procedures and requirements for drug packaging filing shall be formulated and released by the Drug Evaluation Center.

　　Article 80 The following changes shall be reported by the holder in the annual report:

（1） Minor changes in the drug production process;

（2） Other changes required to be reported by the National Drug Administration.

　　Article 81 Supplementary applications submitted after the listing of drugs that require verification and inspection shall be conducted in accordance with the relevant drug registration verification and inspection procedures in these Measures.

Section 2 Drug Reregistration

　　Article 82 The holder shall apply for re registration six months before the expiration of the drug registration certificate. The application for re registration of domestically produced drugs shall be submitted by the holder to the drug regulatory department of the province, autonomous region, or municipality directly under the central government where the holder is located, and the application for re registration of overseas produced drugs shall be submitted by the holder to the drug evaluation center.

　　Article 83 After the acceptance of the drug re registration application, the drug regulatory department or drug evaluation center of the province, autonomous region, or municipality directly under the central government shall review the holder's post marketing evaluation and adverse reaction monitoring of the drug in accordance with the drug approval certificate and the requirements of the drug regulatory department, as well as the changes in information stated in the drug approval certificate. If the requirements are met, the drug shall be re registered, Send a drug re registration approval notice. Those who do not comply with the regulations shall not be re registered and shall be reported to the National Drug Administration for the cancellation of the drug registration certificate.

　　Article 84 Under any of the following circumstances, no further registration shall be granted:

　　（

1） Failure to apply for re registration upon expiration of the validity period;

（2） During the validity period of the drug registration certificate, the holder is unable to fulfill the responsibility of continuously inspecting the quality, efficacy, and adverse reactions of the drug;

（3） Failure to complete the drug approval certificate documents and research work required by the drug regulatory department within the specified time limit without reasonable reasons;

（4） After evaluation after listing, it belongs to the category of uncertain therapeutic effect, significant adverse reactions, or endangering human health due to other reasons;

（5） Other situations where re registration is not allowed as stipulated by laws and administrative regulations.

　　For drugs that are not re registered, the drug registration certificate shall be cancelled upon expiration.

Chapter 6 Acceptance, Withdrawal of Applications, Approval Decisions, and Dispute Resolution

　　Article 85 After receiving the drug registration application, the drug regulatory department shall conduct a formal review and make a decision on whether to accept it based on the following situations:

　　（1） If the application does not require administrative permission according to law, a decision on rejection shall be made immediately and the reasons shall be explained.

　　（2） If the application matters do not fall within the scope of the department's authority according to law, a decision on rejection shall be made immediately and the applicant shall be notified to apply to the relevant administrative organs.

　　（3） If there are errors in the application materials that can be corrected on the spot, the applicant should be allowed to correct them on the spot; If the corrected application materials are complete and in accordance with the legal form, they shall be accepted.

　　（4） If the application materials are incomplete or do not comply with the legal form, the applicant shall be notified on the spot or within five days of all the necessary corrections. If the application materials need to be returned together with the notification according to regulations, they should be returned. The applicant shall complete the necessary corrections within thirty days. If the applicant fails to make corrections within the deadline without justifiable reasons, it shall be deemed as giving up the application and there is no need to make a decision not to accept it. If the applicant is not notified to make corrections within the prescribed time limit, it shall be deemed accepted from the date of receiving the application materials.

　　（5） If the application items fall within the scope of the department's authority, and the application materials are complete and in accordance with the legal form, or if the applicant submits all necessary supplementary and corrected materials as required, the drug registration application shall be accepted.

　　After the acceptance of the drug registration application, if the applicant needs to pay fees, the applicant shall pay the fees in accordance with the regulations. If the applicant fails to pay the fees within the prescribed time limit, the drug registration review and approval shall be terminated.

　　Article 86 After the acceptance of the drug registration application, if there are new discoveries of drug safety, the applicant shall promptly report and supplement relevant materials.

　　Article 87 After the acceptance of the drug registration application, if the applicant needs to supplement new technical materials on the basis of the original application materials, the Drug Evaluation Center shall, in principle, propose a request for supplementary materials, list all issues, and notify the applicant in writing to supplement the submitted materials within 80 days. The applicant shall submit all supplementary materials as required in one go, and the time for supplementary materials shall not be included in the drug review deadline. After receiving all the supplementary information from the applicant, the Drug Evaluation Center will initiate the review, and the review deadline will be extended by one-third; If the priority review and approval process is applicable, the review time limit shall be extended by one quarter.

　　If the applicant does not need to provide new technical information and only needs to explain the original application materials, the Drug Evaluation Center shall notify the applicant to submit relevant explanations within five days as required.

　　If the Drug Evaluation Center believes that there are substantial defects that cannot be corrected, it will no longer require the applicant to provide additional information. Make a decision not to approve based on existing application materials.

　　Article 88 During the review period, no new technical information shall be added to the application for clinical trials of drugs or supplementary applications during clinical trials of drugs; If new research is needed, the applicant can reapply after withdrawal.

　　Article 89 After the acceptance of the drug registration application, the applicant may withdraw the application. If the applicant agrees to withdraw the application, the Drug Evaluation Center or the drug regulatory department of the province, autonomous region, or municipality directly under the central government shall terminate its registration procedures and notify the technical institutions for drug registration verification and inspection. If any illegal behavior such as concealing the truth or providing false information is found during the review, verification, and inspection process, it shall be dealt with in accordance with the law, and the applicant shall not withdraw the drug registration application.

　　Article 90 During the drug registration period, if the evaluation conclusion is not passed, the drug evaluation center shall inform the applicant of the reasons for not passing, and the applicant may raise objections to the drug evaluation center within fifteen days. The Drug Evaluation Center conducts a comprehensive evaluation based on the applicant's objections and provides feedback to the applicant.

　　If the applicant still has objections to the comprehensive evaluation results, the Drug Evaluation Center shall, in accordance with regulations, organize an expert consultation committee to conduct argumentation within fifty days, and form the final evaluation conclusion based on the expert argumentation results.

　　The applicant's objection and expert argumentation time are not included in the evaluation deadline.

　　Article 91 During the drug registration period, if the applicant believes that staff members have violated regulations or engaged in non-standard behavior in the acceptance, review, verification, inspection, and approval of drug registration, they may file a complaint and report to their unit or higher-level authority.

　　Article 92 

If the drug registration application meets the statutory requirements, it shall be approved.

The application for drug registration shall not be approved under any of the following circumstances:

　　（

1） The research materials applied for drug clinical trials are insufficient to support the conduct of drug clinical trials or cannot guarantee the safety of subjects;

（2） The application materials show that there are significant defects in the safety, effectiveness, and quality controllability of the applied drug;

（3） The application materials cannot prove the safety, effectiveness, and quality controllability of the drug, or it is evaluated that the risk of the drug outweighs the benefit;

（4） The applicant fails to supplement the information within the prescribed time limit;

（5） The applicant refuses to accept or fails to accept the drug registration verification or inspection within the prescribed time limit without justifiable reasons;

（6） During the drug registration process, the applicant believes that the application materials are untrue and cannot prove their authenticity;

（7） The on-site verification or sample inspection results of drug registration do not comply with regulations;

（8） Other situations that should not be approved as stipulated by laws and regulations.

　　Article 93 After the approval of the drug registration application is completed, if the applicant has objections to the administrative licensing decision, they may file an administrative reconsideration or administrative lawsuit in accordance with the law.

Chapter 7 Work Time Limit

　　Article 94 本The time limit specified in the method is the maximum time for the acceptance, review, verification, inspection, approval, and other work of drug registration. The time limit for priority review and approval procedures shall be implemented in accordance with the relevant provisions of priority review and approval.

　　Professional technical institutions such as drug evaluation centers should clarify their own work procedures and time limits, and make them publicly available to the public。

　　Article 95 After receiving the drug registration application, the drug regulatory department shall conduct a formal review and make a decision on acceptance, correction, or rejection within five days.

　　Article 96 The time limit for drug registration review shall be implemented in accordance with the following provisions:

（1） The review and approval time limit for drug clinical trial applications and supplementary applications during drug clinical trials is 60 days;

（2） The review time limit for the application for drug marketing license is 200 days, among which the review time limit for the priority review and approval procedure is 130 days. The review time limit for the priority review and approval procedure for rare disease drugs that are urgently needed to be listed overseas is 70 days;

（3） The review time limit for separately applying for the imitation of domestically listed chemical raw materials is 200 days;

（4） The review time limit for supplementary applications for approval type changes is 60 days, and for supplementary applications for consolidated application matters, the review time limit is 80 days. Among them, the review time limit for clinical trial research data review and drug registration verification inspection is 200 days;

（5） The time limit for approving the generic name of a drug is thirty days;

（6） The suitability review deadline for over-the-counter drugs is 30 days.

　　The time limit for associated review is consistent with the review time limit for its associated drug formulation.

　　Article 97 The time limit for drug registration verification shall be implemented in accordance with the following provisions:

（1） The Drug Evaluation Center shall notify the Drug Verification Center to initiate the verification within forty days after the acceptance of the drug registration application, and notify the applicant at the same time;

（2） In principle, the Drug Verification Center shall complete the on-site verification of drug registration and production forty days before the expiration of the evaluation deadline, and provide feedback on the verification situation, verification results, and other relevant materials to the Drug Evaluation Center.

　　Article 98 The time limit for drug registration inspection shall be implemented in accordance with the following regulations:

（1） The time limit for sample inspection is 60 days, and the time limit for simultaneous sample inspection and standard review is 90 days;

（2） The time limit for supplementing information during the drug registration inspection process is 30 days;

（3） In principle, drug inspection institutions shall complete the relevant work of drug registration inspection 40 days before the expiration of the evaluation deadline, and provide feedback on drug standard review opinions and inspection reports to the drug evaluation center.

　　Article 99 The time limit for the review and approval of drug re registration is 120 days.

　　Article 100 The administrative approval decision shall be made within 20 days.

　　Article 101 The drug regulatory department shall issue and deliver relevant administrative license documents within ten days from the date of making the decision on drug registration and approval.

　　Article 102 If it is necessary to extend the time limit due to special circumstances such as variety characteristics and evaluation, verification, and inspection work, the extended time limit shall not exceed half of the original time limit. After approval by the head of relevant technical institutions such as drug evaluation, verification, and inspection, the extended time limit shall be notified to the applicant in writing by the technical institution, and other relevant technical institutions shall be notified.

　　Article 103 The following time is not included in the relevant work time limit:

（1） The time taken by the applicant to supplement information, rectify after verification, and verify production processes, quality standards, and instructions as required;

（2） Delays in verification, inspection, expert consultation meetings, etc. due to the applicant's reasons;

（3） The time occupied during the suspension of the review and approval process in accordance with laws and regulations;

（4） The time occupied by overseas verification when initiating overseas verification.

Chapter 8 Supervision and Management

　　Article 104 The National Drug Administration is responsible for supervising, assessing, evaluating, and guiding the drug registration management work undertaken by relevant professional and technical institutions such as the Drug Evaluation Center, as well as the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government.

　　Article 105 The drug regulatory department shall supervise and inspect drug development activities in accordance with laws and regulations. If necessary, it may conduct extended inspections on units and individuals providing products or services for drug development. Relevant units and individuals shall cooperate and shall not refuse or conceal.

　　Article 106 The Information Center is responsible for establishing drug variety archives, implementing coding management for drugs, collecting information such as drug registration and application, safety related reports during clinical trials, reviews, verifications, inspections, approvals, and approval, filing, and reporting of changes after drug launch, and continuously updating them. The relevant regulations for the management of drug variety archives and codes shall be formulated and announced by the Information Center.

　　Article 107 The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government shall organize daily supervision and inspection of non clinical safety evaluation and research institutions, drug clinical trial institutions, and other compliance with the quality management standards for non clinical drug research and drug clinical trial within their jurisdiction, and supervise their continuous compliance with legal requirements. The National Drug Administration shall conduct supervision and inspection of non clinical drug safety evaluation research institutions, drug clinical trial institutions, and other research institutions as needed.

　　Article 108 The National Drug Administration has established a drug safety credit management system, and the Drug Verification Center is responsible for establishing drug safety credit files for non clinical drug safety evaluation research institutions and drug clinical trial institutions, recording the issuance of licenses, daily supervision and inspection results, and investigation and punishment of illegal behaviors, and disclosing them to the public in accordance with the law and updating them in a timely manner. The drug regulatory department shall increase the frequency of supervision and inspection for those with poor credit records, and may implement joint punishment in accordance with national regulations. The relevant systems for drug safety credit records of non clinical drug safety evaluation research institutions and drug clinical trial institutions shall be formulated and announced by the Drug Verification Center.

　　Article 109 

The National Drug Administration shall, in accordance with the law, disclose the list of drug registration and approval matters, legal basis, approval requirements, and processing time limit to the society, disclose the progress of drug registration to the applicant, and disclose the review conclusions and basis of approved drugs for marketing to the society, as well as any illegal and irregular behaviors discovered during supervision and inspection, and accept social supervision.

The instructions for approved marketed drugs should be publicly available and updated in a timely manner. Among them, vaccines should also be publicly labeled and updated in a timely manner.

Without the consent of the applicant, the drug regulatory department, professional technical institutions and their staff, as well as personnel participating in expert reviews, shall not disclose the trade secrets, undisclosed information, or confidential business information submitted by the applicant, except as otherwise provided by law or involving national security and major social public interests.

　　Article 110 If one of the following circumstances occurs, the National Drug Administration shall cancel the drug registration certificate and make it public:

（1） The holder voluntarily proposes to cancel the drug registration certificate;

（2） Those who are not allowed to re register according to the provisions of these Measures;

（3） The holder's drug registration certificate, drug production license, or other administrative licenses have been revoked or revoked in accordance with the law;

（4） According to Article 83 of the Drug Administration Law, the therapeutic effect is uncertain, there are significant adverse reactions, or there are other reasons that endanger human health;

（5） According to Article 61 of the Vaccine Management Law, after evaluation after listing, it is found that the abnormal response to vaccination is serious or poses a threat to human health for other reasons;

（6） According to Article 62 of the Vaccine Management Law, it is found through post market evaluation that the product design, production process, safety, effectiveness, or quality controllability of the vaccine variety is significantly inferior to other vaccine varieties for the prevention and control of the same disease;

（7） Violating laws and administrative regulations, failing to complete the corresponding research work within the prescribed time limit as required by the drug approval certificate or the drug regulatory department without reasonable reasons;

（8） Other situations where the drug registration certificate should be revoked in accordance with the law.

Chapter 9 Legal Liability

　　Article 111 In the process of drug registration, those who provide false certificates, data, materials, samples, or use other means to obtain clinical trial licenses or drug registration licenses shall be dealt with in accordance with Article 123 of the Drug Administration Law.

　　Article 112 Those who apply for clinical trials of vaccines, provide false data, materials, samples or engage in other deceptive behaviors during registration shall be dealt with in accordance with Article 81 of the Vaccine Management Law.

　　Article 113 In the process of drug registration, if non clinical safety evaluation research institutions, drug clinical trial institutions, etc. fail to comply with the quality management standards for non clinical drug research and drug clinical trial in accordance with regulations, they shall be dealt with in accordance with Article 126 of the Drug Administration Law.

　　Article 114 Those who conduct drug clinical trials without approval shall be dealt with in accordance with Article 125 of the Drug Administration Law; If the bioequivalence test is not filed, it shall be handled in accordance with Article 127 of the Drug Administration Law.

　　Article 115 During the clinical trial of drugs, if safety issues or other risks are found, and the clinical trial applicant fails to adjust the clinical trial plan, suspend or terminate the clinical trial in a timely manner, or fails to report to the National Drug Administration, it shall be dealt with in accordance with Article 117 of the Drug Administration Law.

　　Article 116 If the applicant violates the provisions of Article 28 and Article 33 of these Measures and falls under any of the following circumstances, they shall be ordered to make corrections within a specified period of time; Those who fail to make corrections within the prescribed time limit shall be fined not less than 10000 yuan but not more than 30000 yuan:

　　（1） Failure to register on the drug clinical trial registration and information disclosure platform as required before conducting drug clinical trials;

　　（2） Failure to submit safety update reports during the research and development period as required;

　　（3） The clinical trial results and other information have not been registered after the completion of the drug clinical trial.

　　Article 117 If a drug inspection institution issues a false inspection report when undertaking the inspection work required for drug registration, it shall be dealt with in accordance with Article 138 of the Drug Administration Law.

　　Article 118 Those who approve clinical trials of drugs that do not meet the conditions and issue drug registration certificates for drugs that do not meet the conditions shall be dealt with in accordance with Article 147 of the Drug Administration Law.

　　Article 119 If the drug regulatory department and its staff engage in illegal or irregular activities during the drug registration management process, they shall be dealt with in accordance with relevant laws and regulations.

Chapter 10 Supplementary Provisions

　　Article 120 The registration application for drugs with other special management regulations, such as anesthetic drugs, psychotropic drugs, medical toxic drugs, radioactive drugs, and pharmaceutical precursor chemicals, shall not only be handled in accordance with the provisions of these Measures, but also comply with other relevant national regulations.

　　Article 121 The standards for exporting vaccines should comply with the standards or contract requirements of the importing country (region).

　　Article 122 The combination of pharmaceutical and mechanical products to be applied for registration, if similar products have been defined as drugs by their attributes, shall be declared as drugs; If the product attributes have not been defined yet, the applicant shall apply to the State Administration for Drug Administration for product attribute definition before applying for registration. For those whose attributes are defined as drugs, registration shall be carried out in accordance with the procedures specified in these Measures. The research materials belonging to the medical device part shall be reviewed and concluded by the Medical Device Technical Evaluation Center of the State Drug Administration, and then transferred to the Drug Evaluation Center for comprehensive evaluation.

　　Article 123 The format of the approval number for domestically produced drugs is: Guoyao Zhunzi H (Z, S)+four digit year number+four digit sequence number. The format of the approval number for the production of drugs in Hong Kong, Macau, and Taiwan is: National Drug Approval Letter H (Z, S) C+four digit year number+four digit sequence number.

The format of the approval number for overseas production of drugs is: Guoyao Zhunzi H (Z, S) J+four digit year number+four digit sequence number.

Among them, H represents chemical drugs, Z represents traditional Chinese medicine, and S represents biological products.

The drug approval number shall not be changed due to changes in registration matters after listing.

If there are other regulations on traditional Chinese medicine, they shall prevail.

　　Article 124 The electronic documents of drug registration approval certificates and raw material drug approval documents produced by the drug regulatory department have the same legal effect as the paper documents.

　　Article 125 The deadline specified in these measures shall be calculated based on working days.

　　Article 126 This measure shall come into effect from July 1, 2020. The "Drug Registration Management Measures" promulgated by Order No. 28 of the former State Food and Drug Administration on July 10, 2007 shall be abolished simultaneously.