Measures for the Supervision and Administration of Drug Production

(Promulgated by Order No. 28 of the State Administration for Market Regulation on January 22, 2020, effective from July 1, 2020)

Chapter 1 General Provisions

Article 1: In order to strengthen the supervision and management of drug production and standardize drug production activities, in accordance with laws such as the "Drug Administration Law of the People's Republic of China" (hereinafter referred to as the "Drug Administration Law"), the "Traditional 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", and the "Implementation Regulations of the Drug Administration Law of the People's Republic of China" Administrative regulations are formulated to formulate these measures.

Article 2: The production, supervision and management activities of drugs listed within the territory of the People's Republic of China shall comply with these Measures.

Article 3: Those engaged in drug production activities shall comply with laws, regulations, rules, standards, and norms, and ensure the authenticity, accuracy, completeness, and traceability of the entire process information.

To engage in drug production activities, approval must be obtained from the drug regulatory department of the province, autonomous region, or municipality directly under the central government where the activity is located, a drug production license must be obtained in accordance with the law, and drug production quality management standards must be strictly followed to ensure that the production process continues to meet legal requirements.

The holder of a drug marketing license shall establish a drug quality assurance system, fulfill the responsibility of drug marketing release, and be responsible for the quality of the drugs obtained from the drug registration certificate.

Traditional Chinese medicine slices production enterprises shall fulfill the relevant obligations of drug marketing license holders to ensure that the production process of traditional Chinese medicine slices continues to comply with legal requirements.

Raw material drug production enterprises should organize production in accordance with approved production processes, strictly comply with drug production quality management standards, and ensure that the production process continues to meet legal requirements.

Manufacturers of excipients, packaging materials and containers that come into direct contact with drugs, as well as other units and individuals engaged in drug-related production activities, shall bear corresponding responsibilities in accordance with the law.

Article 4: Holders of drug marketing licenses and drug production enterprises shall establish and implement a drug traceability system, assign traceability labels to drug sales packaging units at all levels in accordance with regulations, implement drug traceability through information technology, timely and accurately record and store drug traceability data, and provide traceability information to the drug traceability collaborative service platform.

Article 5: The National Drug Administration shall be responsible for the supervision and management of drug production nationwide, and shall supervise and guide the drug production supervision and management work of the 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 are responsible for the supervision and management of drug production within their respective administrative regions, and are responsible for the licensing, inspection, and punishment of drug production processes.

The Food and Drug Audit and Inspection Center of the National Drug Administration (hereinafter referred to as the Inspection Center) organizes the formulation of technical specifications and documents for drug inspection, undertakes overseas inspections and organizes vaccine inspections, analyzes and evaluates the risks found during inspections, draws inspection conclusions, and proposes disposal suggestions. It is responsible for guiding and evaluating the quality management system of drug inspection institutions in various provinces, autonomous regions, and municipalities directly under the central government.

The Information Center of the National Drug Administration is responsible for the construction and management of the collaborative service platform for drug traceability, drug safety credit archives, and unified coding of drug production sites.

Professional technical institutions for drug review, inspection, verification, monitoring, and evaluation established or designated by the drug regulatory department in accordance with the law shall undertake relevant technical work and issue technical conclusions in accordance with their responsibilities, providing technical support for drug production supervision and management.

Chapter 2 Production License

Article 6: To engage in drug production, the following conditions shall be met:

（1） Having legally qualified pharmaceutical technicians, engineering technicians, and corresponding technical workers, legal representatives, enterprise leaders, production management leaders (hereinafter referred to as production leaders), quality management leaders (hereinafter referred to as quality leaders), quality authorized persons, and other relevant personnel who meet the conditions stipulated in the Drug Management Law and the Vaccine Management Law;

（2） Having factories, facilities, equipment, and a hygienic environment suitable for drug production;

（3） Having institutions and personnel capable of quality management and inspection of the produced drugs;

（4） Having necessary instruments and equipment for quality management and inspection of the produced drugs;

（5） There are rules and regulations to ensure the quality of drugs, and they comply with the requirements of drug production quality management standards.

Those engaged in vaccine production activities should also meet the following conditions:

（1） Having a moderate scale and sufficient capacity reserves;

（2） Having systems, facilities, and equipment to ensure biosafety;

（3） Meet the needs of disease prevention and control.

Article 7: Applicants engaged in the production of preparations, raw materials, and traditional Chinese medicine decoction pieces shall apply to the drug regulatory department of the province, autonomous region, or municipality directly under the central government where they are located in accordance with these Measures and the requirements for application materials stipulated by the State Drug Administration.

The holder of a drug marketing license who entrusts others to produce preparations shall meet the conditions stipulated in Article 6, Paragraph 1, Items 1, 3, and 5 of these Measures, and sign a commission agreement and quality agreement with the qualified drug production enterprise. The relevant agreement and actual production site application materials shall be merged and submitted to the drug regulatory department of the province, autonomous region, or municipality directly under the central government where the drug marketing license holder is located, Apply for a drug production license in accordance with the provisions of these Measures.

The applicant shall be responsible for the authenticity of all the contents of their application materials.

Article 8: After receiving the application, the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government shall handle it according to the following situations:

（1） 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 authorities;

（2） If the application does not require an administrative license in accordance with the law, the applicant shall be notified immediately that it is not accepted;

（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;

（4） If the application materials are incomplete or do not meet the requirements of the formal examination, a notice of correction of the materials shall be sent to the applicant on the spot or within five days, informing the applicant of all the content that needs to be corrected at once. If the applicant fails to inform within the time limit, it shall be deemed accepted from the date of receiving the application materials;

（5） If the application materials are complete and meet the requirements for formal examination, or if the applicant submits all necessary supplementary materials as required, they will be accepted.

If the drug regulatory department of a province, autonomous region, or municipality directly under the Central Government accepts or refuses to accept an application for a drug production license, it shall issue a notice of acceptance or refusal stamped with the department's special seal and dated.

Article 9: The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government shall make a decision within 30 days from the date of acceptance.

If it meets the requirements after examination, it shall be approved and a drug production license shall be issued within ten days from the date of the written approval decision; If it does not comply with the regulations, a written decision shall be made not to approve and the reasons shall be explained.

The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government shall organize technical review and evaluation of application materials, as well as on-site inspection in accordance with relevant regulations such as drug production quality management standards.

Article 10: The drug supervision and management departments of provinces, autonomous regions, and municipalities directly under the central government shall publicize on the websites and office premises of administrative organs the conditions, procedures, deadlines, a list of all materials required to be submitted, and a sample text of the application form required to apply for a drug production license.

The relevant information on the issuance of drug production licenses by the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government shall be made public, and the public has the right to consult.

Article 11: When the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government review the application for a drug production license, they shall publicly disclose the approval results and provide conditions to facilitate the applicant's inquiry and approval process.

Without the consent of the applicant, the drug regulatory department, professional technical institutions, and their staff 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 or significant social public interests.

Article 12: If the application for a drug production license directly involves a significant interest relationship between the applicant and others, the applicant and interested parties shall have the right to apply for a hearing in accordance with laws and regulations.

When reviewing the application of drug production enterprises, if the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government believe that it involves public interests, they shall make a public announcement and hold a hearing.

Article 13: The validity period of a drug production license is five years, divided into original and duplicate copies. The format of the drug production license shall be uniformly formulated by the National Drug Administration. The electronic certificate of the drug production license has the same legal effect as the paper certificate.

Article 14: A drug production license shall specify the license number, classification code, enterprise name, unified social credit code, domicile (business premises), legal representative, enterprise leader, production leader, quality leader, quality authorized person, production address and scope, issuing authority, issuing date, validity period, and other items.

The enterprise name, unified social credit code, domicile (business premises), legal representative, and other items should be consistent with the relevant content stated in the business license issued by the market supervision and management department.

Article 15: The items stated in the drug production license are divided into license items and registration items.

The licensing matters refer to the production address and scope, etc.

Registration items refer to the name of the enterprise, address (business premises), legal representative, person in charge of the enterprise, production manager, quality manager, quality authorized person, etc.

Article 16: If the licensing items of a drug production license are changed, an application for the change of the drug production license shall be submitted to the original issuing authority. Without approval, no unauthorized changes shall be made to the licensing matters.

The original issuing authority shall make a decision on whether to approve the change within 15 days from the date of receiving the enterprise change application. If no changes are made, the reasons shall be explained in writing and the applicant shall be informed of the right to apply for administrative reconsideration or file an administrative lawsuit in accordance with the law.

When changing the production address or scope, the pharmaceutical production enterprise shall submit relevant materials related to the change content in accordance with the provisions of Article 6 of these Measures and the relevant technical requirements for the change, and submit them to the drug regulatory department of the province, autonomous region, or municipality directly under the central government for review and decision.

For the construction, renovation, or expansion of workshops or production lines in their original or remote locations, they shall comply with relevant regulations and technical requirements, submit relevant materials related to the changes, and report to the drug regulatory department of the province, autonomous region, or municipality directly under the central government where they are located for drug production quality management compliance inspection. The inspection results shall be notified to the enterprise. If the inspection results meet the regulations and the product meets the release requirements, it can be put on the market for sale. The relevant changes should be stated in the copy of the drug production license.

If the above changes involve the content specified in the drug registration certificate and its attachments, they shall be approved by the drug regulatory department of the province, autonomous region, or municipality directly under the central government, and then reported to the Drug Evaluation Center of the National Drug Administration for updating the relevant content of the drug registration certificate and its attachments.

Article 17: If a change is made to the registration items of a drug production license, an application for registration of a change in the drug production license shall be submitted to the original issuing authority within 30 days after the market supervision and management department approves the change or the enterprise completes the change. The original issuing authority shall handle the change procedures within ten days from the date of receiving the enterprise change application.

Article 18: After the change of the drug production license, the original issuing authority shall record the content and time of the change on the copy of the drug production license, and reissue the original drug production license according to the changed content. The original drug production license shall be recovered, and the termination period of the changed drug production license shall remain unchanged.

Article 19: If the validity period of a drug production license expires and it is necessary to continue producing drugs, an application for reissuing the drug production license shall be submitted to the original issuing authority six months before the expiration of the validity period.

The original issuing authority shall review the compliance of the enterprise with drug management laws and regulations, drug production quality management standards, and the operation of the quality system in accordance with the principles of risk management, and make a decision on whether to allow the drug production license to be reissued before the expiration of its validity period. If a new certificate is granted in accordance with regulations, the original certificate shall be withdrawn and a new certificate shall be issued; If it does not comply with the regulations, make a written decision not to reissue the certificate, explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or file an administrative lawsuit in accordance with the law; If a decision is not made within the deadline, it shall be deemed as agreeing to reissue the certificate and completing the corresponding procedures.

Article 20: In any of the following circumstances, the drug production license shall be cancelled by the original issuing authority and announced:

（1） Proactively applying for the cancellation of drug production license;

（2） Failure to reissue the drug production license upon expiration of its validity period;

（3） The business license has been revoked or cancelled in accordance with the law;

（4） The drug production license has been revoked or revoked in accordance with the law;

（5） Other situations where laws and regulations require the cancellation of administrative licenses.

Article 21: If a drug production license is lost, the holder of the drug marketing license and the drug production enterprise shall apply to the original issuing authority for reissuing the drug production license. The original issuing authority shall reissue the drug production license within ten days according to the original approved items. The license number, validity period, etc. are consistent with the original license.

Article 22: No unit or individual shall forge, alter, lease, lend, or buy or sell drug production licenses.

Article 23: The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government shall update the drug production license issuance, reissuance, change, reissuance, revocation, cancellation, and other related procedures in the drug safety credit file within ten days after the completion of the procedures.

Chapter 3 Production Management

Article 24: Those engaged in drug production activities shall comply with the quality management standards for drug production, produce in accordance with the national drug standards, drug registration standards approved by the drug regulatory department, and production processes. They shall submit and continuously update site management documents in accordance with regulations, conduct risk assessment and continuous improvement of the quality system operation process, and ensure that the entire process of drug production continues to comply with legal requirements. Production, inspection and other records should be complete and accurate, and cannot be fabricated or tampered with.

Article 25: The holder of the vaccine marketing license shall have the necessary factory facilities and equipment for vaccine production and testing, be equipped with qualified management personnel, establish a sound quality management system, and have the ability to produce vaccines that meet the registration requirements. If it is necessary to entrust production beyond the vaccine production capacity, it shall be approved by the National Drug Administration.

Article 26: Those engaged in drug production activities shall comply with the quality management standards for drug production, establish a sound drug production quality management system, cover all factors that affect drug quality, and ensure that the entire process of drug production continues to comply with legal requirements.

Article 27: Holders of drug marketing licenses shall establish a drug quality assurance system, allocate specialized personnel to independently manage drug quality, conduct regular audits of the quality management system of entrusted drug production enterprises and drug trading enterprises, and supervise their continuous quality assurance and control capabilities.

Article 28: The legal representative and main person in charge of the holder of the drug marketing license shall be fully responsible for the quality of the drug and fulfill the following responsibilities:

（1） Equip a dedicated quality manager to independently manage drug quality;

（2） Equip specialized quality authorized personnel to independently fulfill the responsibility of drug release on the market;

（3） Supervise the normal operation of the quality management system;

（4） Regularly conduct quality system audits on drug production related activities of drug production enterprises, suppliers, and other related parties to ensure continuous compliance;

（5） Fulfill the responsibility of change management in accordance with the technical requirements for changes;

（6） Conduct quality evaluation on the entrusted business enterprise and communicate information with the user unit;

（7） Cooperate with the drug regulatory department to conduct extended inspections on drug marketing license holders and relevant parties;

（8） If a major safety incident related to drug quality occurs, it should be reported in a timely manner and risk disposal should be carried out according to the risk management plan formulated by the holder to ensure timely control of the risk;

（9） Responsibilities stipulated by other laws and regulations.

Article 29: The legal representative and main person in charge of a pharmaceutical production enterprise shall be fully responsible for its pharmaceutical production activities and fulfill the following responsibilities:

（1） Equip a dedicated quality manager to independently manage drug quality, supervise the implementation of quality management standards, ensure appropriate production process control and quality control, and ensure that drugs comply with national drug standards and drug registration standards;

（2） Equip specialized quality authorized personnel to fulfill the responsibility of drug release from the factory;

（3） Supervise the normal operation of the quality management system, ensure the control of the drug production process, quality control, and the authenticity of records and data;

（4） Major safety incidents related to drug quality should be reported in a timely manner and risk disposal should be carried out in accordance with the risk management plan formulated by the enterprise to ensure timely control of risks;

（5） Responsibilities stipulated by other laws and regulations.

Article 30: Holders of drug marketing licenses and drug production enterprises shall conduct annual health examinations and establish health records for personnel who come into direct contact with drugs, in order to avoid personnel who suffer from infectious diseases or other diseases that may contaminate drugs from engaging in direct contact with drug production activities.

Article 31: Holders of drug marketing licenses and drug production enterprises shall carry out quality management activities such as risk assessment, control, verification, communication, and review in drug production, and take effective risk control measures in a timely manner for identified risks to ensure product quality.

Article 32: When engaging in drug production activities, suppliers or production enterprises of raw materials, excipients, packaging materials and containers that come into direct contact with drugs shall be audited to ensure that their purchases and use comply with regulatory requirements.

The raw materials and auxiliary materials required for the production of drugs should comply with the pharmaceutical requirements and the relevant requirements of production quality management standards. Packaging materials and containers that come into direct contact with drugs should comply with pharmaceutical requirements and meet standards to ensure human health and safety.

Article 33: Production enterprises of raw materials, excipients, packaging materials and containers that come into direct contact with drugs that have been approved or approved through related review and approval shall comply with the quality management standards formulated by the National Drug Administration and the relevant requirements of related review and approval, ensure the continuous compliance of the quality assurance system, and accept the quality audit of the drug marketing license holder, Accept supervision and inspection or extended inspection by the drug regulatory department.

Article 34: Pharmaceutical production enterprises shall determine the necessary confirmation and validation, and implement them in accordance with the confirmation and validation plan. Regularly evaluate facilities, equipment, production processes, and cleaning methods to confirm that they are continuously in a validated state.

Article 35 Pharmaceutical production enterprises shall take control measures to prevent pollution, cross contamination, confusion, and errors, regularly inspect and evaluate the applicability and effectiveness of control measures, to ensure that the drugs meet the prescribed national pharmaceutical standards and drug registration standards, and meet the requirements of pharmaceutical production quality management standards.

Holders of drug marketing licenses and drug production enterprises are not allowed to produce other products in drug production factories that have adverse effects on drug quality.

Article 36: Measures should be taken to reduce the risk of confusion and errors in drug packaging operations, and drug packaging should ensure that the drug is not contaminated during storage and transportation during its validity period.

The statements in the drug instructions and labels should be scientific, standardized, and accurate, and the text should be clear and easy to distinguish. They should not be modified or supplemented by pasting, cutting, or erasing.

Article 37 Pharmaceutical production enterprises shall establish regulations for the release of drugs from the factory, clarify the standards and conditions for the release, and review the quality inspection results, key production records, and deviation control of drugs, and conduct quality inspections of drugs. Those that meet the standards and conditions can only be released from the factory after being signed by the quality authorized person.

The holder of a drug marketing license shall establish a drug marketing release procedure, review the inspection results and release documents of the drug released from the factory by the drug production enterprise, and obtain the signature of the quality authorized person before it can be marketed and released.

Traditional Chinese medicine slices that meet the national drug standards or the processing standards formulated by the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government can only be manufactured and sold.

Article 38: Holders of drug marketing licenses and drug production enterprises shall conduct annual self inspections, monitor the implementation of drug production quality management standards, evaluate whether the enterprise meets relevant regulatory requirements, and propose necessary corrective and preventive measures.

Article 39: Holders of drug marketing licenses shall establish an annual reporting system and report annually to the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government on drug production and sales, post marketing research, risk management, and other information in accordance with the regulations of the National Drug Administration.

The holder of the vaccine marketing license shall submit an annual report to the National Drug Administration in accordance with regulations.

Article 40: Holders of drug marketing licenses shall continue to conduct drug risk and benefit assessments and controls, formulate post marketing drug risk management plans, actively conduct post marketing research, further confirm the safety, effectiveness, and quality controllability of drugs, and strengthen the continuous management of drugs that have already been marketed.

Article 41: Holders of drug marketing licenses shall establish a drug vigilance system and carry out drug vigilance work in accordance with the drug vigilance quality management standards formulated by the State Drug Administration.

Holders of drug marketing licenses and drug production enterprises shall regularly inspect the quality, efficacy, and adverse reactions of their own drugs. If suspected adverse reactions are found, they should be reported promptly as required.

Article 42: If the holder of a drug marketing license entrusts the production of drugs, it shall comply with the relevant provisions of drug management.

If the holder of the drug marketing license entrusts a qualified drug production enterprise to produce drugs, it shall evaluate the quality assurance and risk management capabilities of the entrusted party, and sign a quality agreement and commission agreement with it in accordance with the requirements of the quality agreement guidelines for drug commissioned production formulated by the National Drug Administration, to supervise the entrusted party to fulfill the obligations stipulated in the relevant agreement.

The entrusted party shall not entrust the entrusted production of drugs to a third party for further production.

Raw materials approved or approved through related review shall be produced by themselves and shall not be entrusted to others for production.

Article 43: Holders of drug marketing licenses shall manage and control production process changes in accordance with the requirements of drug production quality management standards, and formulate process procedures based on the approved production process. Production process changes should be studied, approved, filed or reported in accordance with the law, and subject to supervision and inspection by the drug regulatory department.

Article 44: Holders of drug marketing licenses and drug production enterprises shall conduct annual product quality review, analysis, and recording of the drugs produced according to their varieties, in order to confirm the stability and reliability of the process, as well as the applicability of the current quality standards for raw materials, excipients, and finished products.

Article 45: If there is a change in the quality management system related organizational structure, enterprise head, production head, quality head, or quality authorized person of a drug marketing license holder or drug manufacturing enterprise, the registration process shall be completed within 30 days from the date of the change.

The holder of the vaccine marketing license shall, within 15 days from the date of change, report to the drug regulatory department of the province, autonomous region, or municipality directly under the central government the changes in key positions such as production manager, quality manager, and quality authorized person.

Article 46: For drugs listed in the list of shortage drugs in the national production suspension report, if the drug marketing license holder stops production, they shall report to the drug regulatory department of the province, autonomous region, or municipality where they are located six months before the planned production suspension is implemented; If an unexpected shutdown occurs, it shall be reported to the drug regulatory department of the province, autonomous region, or municipality directly under the central government within three days. If necessary, report to the National Drug Administration.

After receiving the report, the drug supervision and management department shall promptly notify the leading unit of the consultation and linkage mechanism for the supply guarantee of shortage drugs at the same level.

Article 47: If the holder of a drug marketing license is an overseas enterprise, it shall designate an enterprise legal person within China to fulfill the obligations of the drug marketing license holder as stipulated in the Drug Administration Law and these Measures, and be responsible for coordinating and cooperating with overseas inspection work.

Article 48: If the production site of a drug marketing license holder is located overseas, production shall be organized in accordance with the provisions of the Drug Administration Law and these Measures, and overseas inspection work shall be coordinated.

Chapter 4 Supervision and Inspection

Article 49: The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government are responsible for supervising and managing the holders of drug marketing licenses and the production enterprises of formulations, chemical raw materials, and traditional Chinese medicine decoction pieces within their respective administrative regions.

The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government shall conduct daily supervision and inspection on suppliers and production enterprises of raw materials, excipients, packaging materials and containers that come into direct contact with drugs, and if necessary, carry out extended inspections.

Article 50: If the holder of the drug marketing license and the entrusted production enterprise are not in the same province, autonomous region, or municipality directly under the Central Government, the drug regulatory department of the province, autonomous region, or municipality where the drug marketing license holder is located shall be responsible for supervising and managing the drug marketing license holder, and the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the entrusted production enterprise is located shall be responsible for supervising and managing the entrusted production enterprise. The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government shall strengthen mutual notification of supervision and inspection information, and timely update the supervision and inspection information into the drug safety credit archives. They may conduct investigations based on the notification situation and the update of regulatory information in the drug safety credit archives, and impose administrative sanctions on drug marketing license holders or entrusted production enterprises in accordance with the law. If necessary, joint inspections may be carried out.

Article 51: The drug regulatory department shall establish and improve a professional and specialized inspector system, clarify the qualification standards, inspection responsibilities, hierarchical management, ability training, behavioral norms, performance evaluation, and exit procedures of inspectors, and improve the professional quality and work level of inspectors. Inspectors should be familiar with drug laws and regulations and possess professional knowledge of drugs.

The drug supervision and management department should allocate an adequate team of inspectors based on regulatory powers, the scale of the drug industry, and inspection tasks to ensure the needs of inspection work. Regions with high-risk drug production enterprises such as vaccines should also be equipped with a corresponding number of drug inspectors with skills and experience in inspecting high-risk drugs such as vaccines.

Article 52: The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government shall, according to regulatory needs, conduct pre market conformity inspections of drug production quality management standards for applicants holding drug production licenses and their entrusted production enterprises in accordance with the following requirements:

（1） Varieties that have not passed the conformity inspection of drug production quality management standards that are suitable for the production conditions of the drug shall undergo a pre market conformity inspection of drug production quality management standards. Among them, if on-site verification of drug registration is required for the planned production of drugs, the Drug Evaluation Center of the National Drug Administration shall notify the verification center and inform the relevant drug regulatory departments and applicants of the provinces, autonomous regions, and municipalities directly under the central government. The verification center coordinates with the relevant drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government to conduct on-site verification of drug registration and compliance inspection of drug production quality management standards before market launch;

（2） If on-site verification of drug registration is not required for the intended production of drugs, the Drug Evaluation Center of the National Drug Administration shall notify the drug regulatory departments and applicants of the provinces, autonomous regions, and municipalities where the production site is located, and the relevant drug regulatory departments of the provinces, autonomous regions, and municipalities shall conduct pre market drug production quality management standard compliance inspections on their own;

（3） For varieties that have passed the compliance inspection of drug production quality management standards that are suitable for the production conditions of the drug, the relevant drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government shall decide whether to carry out pre market drug production quality management standards compliance inspection based on the principle of risk management.

For conducting pre market compliance inspections of drug production quality management standards, after the inspection is completed, a written report should be formed on the inspection results, etc., as an important basis for drug market supervision. If the compliance inspection of drug production quality management standards before listing involves changes in drug production license matters, the drug regulatory department of the province, autonomous region, or municipality directly under the central government that originally issued the license shall make a decision in accordance with the change procedure.

Commercial scale batches that meet the product release requirements after obtaining the drug registration certificate through the corresponding pre market conformity inspection of drug production quality management standards can be put on the market for sale. Holders of drug marketing licenses should focus on strengthening measures such as production, sales, and risk management of the aforementioned batches of drugs.

Article 53: The main contents of drug production supervision and inspection include:

（1） The implementation of relevant laws and regulations, as well as the implementation of drug production quality management standards, drug vigilance quality management standards, and relevant technical specifications by drug marketing license holders and drug production enterprises;

（2） Whether the drug production activities are consistent with the relevant content stated in the drug variety file;

（3） Implementation of vaccine storage and transportation management standards;

（4） Quality Agreement and Entrustment Agreement for Drug Commissioned Production;

（5） Implementation status of risk management plan;

（6） Change management situation.

Supervision and inspection include permit inspection, routine inspection, causal inspection, and other inspections.

Article 54: The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government shall adhere to the principles of risk management and full process control, formulate annual inspection plans based on risk assessment, and carry out supervision and inspection. The annual inspection plan shall at least include the scope, content, method, focus, requirements, time limit, and institutions responsible for the inspection.

Article 55: The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government shall determine the frequency of inspections based on the characteristics of drug varieties, dosage forms, and control categories, combined with the overall national drug safety situation, drug safety risk warning information, major drug safety incidents and their investigation and handling information, as well as previous inspections, inspections, adverse reaction monitoring, complaints and reports

（1） Conduct inspections at least once a quarter on the production enterprises of anesthetic drugs, first class psychotropic drugs, and pharmaceutical precursor chemicals;

（2） For high-risk drug production enterprises such as vaccines, blood products, radioactive drugs, medical toxic drugs, sterile drugs, etc., the compliance inspection of drug production quality management standards shall not be less than once a year;

（3） For pharmaceutical production enterprises other than the above-mentioned products, a certain proportion of them shall be selected annually to carry out supervision and inspection, but all enterprises within the administrative region shall be inspected within three years;

（4） A certain proportion of suppliers and production enterprises of raw materials, excipients, packaging materials and containers that come into direct contact with drugs shall be selected annually for supervision and inspection. Within five years, all enterprises within the administrative region shall be inspected.

The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government may adjust the frequency of inspections based on the actual situation of drug production supervision within their respective administrative regions.

Article 56: When the National Drug Administration and the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government organize supervision and inspection, they shall formulate inspection plans, clarify inspection standards, truthfully record on-site inspection situations, and carry out sampling inspection or research in accordance with relevant regulations. The inspection conclusion should be clear and clear, and any problems found during the inspection should be notified to the inspected unit in writing. If rectification is needed, the content and deadline for rectification should be proposed, and if necessary, the situation after rectification should be inspected.

When conducting supervision and inspection, the drug regulatory department shall assign two or more inspectors to carry out the supervision and inspection, and the inspectors shall present their law enforcement certificates to the inspected unit. Personnel of the drug regulatory department shall keep confidential any trade secrets they come to know.

Article 57: During supervision and inspection, drug marketing license holders and drug production enterprises shall explain the situation and provide relevant materials according to the inspection needs:

（1） Management documents and change materials for drug production sites;

（2） The supervision, inspection, and rectification implementation of drug production enterprises;

（3） Handling of substandard drug quality;

（4） The development of drug vigilance institutions, personnel, and systems, as well as the monitoring, identification, evaluation, and control of suspected adverse drug reactions;

（5） Materials for conducting post market research on varieties approved with conditions;

（6） Other necessary materials that need to be reviewed.

Article 58: After the on-site inspection is completed, the on-site inspection situation shall be analyzed and summarized, and the risks of defects discovered during the inspection shall be objectively, fairly, and fairly evaluated, and the on-site inspection conclusion shall be drawn.

The dispatching unit is responsible for conducting comprehensive analysis and judgment on the on-site inspection conclusions.

Article 59: If the National Drug Administration and the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government discover defects in drug production management or vaccine storage and transportation management through supervision and inspection, and there is evidence to prove that there may be safety hazards, corresponding measures shall be taken in accordance with the law:

（1） If it basically meets the requirements of drug production quality management standards and needs to be rectified, a warning letter should be issued and corresponding measures such as warning, appointment, and deadline rectification should be taken based on the risk;

（2） If there are quality issues or other safety hazards with drugs, the drug regulatory department shall issue warning letters based on the supervision and inspection results, and take corresponding control measures such as suspending production, sales, use, and import based on the risks.

If there are quality issues or other safety hazards with drugs, the holder of the drug marketing license shall recall the drugs in accordance with the law, but the drug regulatory department of the province, autonomous region, or municipality directly under the central government shall order them to recall.

After the risk is eliminated, the drug regulatory department that takes control measures shall lift the control measures.

Article 60: In the process of conducting drug production supervision and inspection, if any drug quality and safety risks are found, they shall be promptly reported to the dispatching unit. If the drug regulatory department has determined through research that it is a major drug quality and safety risk, it shall promptly report to the higher-level drug regulatory department and the local people's government at the same level.

Article 61: In the process of conducting drug production supervision and inspection, if suspected violations of drug laws, regulations, and rules are found, on-site control measures shall be taken in a timely manner, and evidence collection work shall be carried out in accordance with regulations. The drug supervision and management department shall investigate and punish according to their duties and authorities, and those suspected of committing crimes shall be transferred to the public security organs for handling.

Article 62: The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government shall, in accordance with the law, classify the regulatory information of drug marketing license holders and drug production enterprises within their respective administrative regions into the management of drug safety credit archives, and maintain dynamic updates of relevant data. Regulatory information includes drug production licenses, daily supervision and inspection results, investigation and punishment of illegal behaviors, random inspection of drug quality, records of adverse behaviors, and complaints and reports.

Article 63: The National Drug Administration and the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government shall not obstruct the normal production activities of drug marketing license holders and drug production enterprises in production supervision and management, nor demand or accept property, nor seek other benefits.

Article 64: Individuals and organizations who discover that drug marketing license holders or drug production enterprises engage in illegal production activities have the right to report to the drug regulatory department, which shall promptly verify and handle them in accordance with relevant regulations.

Article 65: In the event of a major safety incident related to drug quality, the holder of the drug marketing license shall immediately take control measures such as sealing up the relevant drugs, their raw materials, auxiliary materials, packaging materials and containers that come into direct contact with the drugs, as well as relevant production lines, and immediately report to the drug regulatory department and relevant departments of the province, autonomous region, or municipality where the drug is located The drug regulatory department of the municipality directly under the central government shall report to the provincial people's government within 24 hours, and at the same time report to the National Drug Administration.

Article 66: The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government shall increase the frequency of supervision and inspection for drug marketing license holders and drug production enterprises with poor credit records, and may implement joint punishment in accordance with national regulations.

Article 67: If the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the central government fail to timely identify systemic risks to drug safety in the production process, fail to timely eliminate potential drug safety hazards within the supervision and management area, or if the provincial people's governments fail to fulfill their drug safety responsibilities and timely eliminate major regional drug safety hazards, the National Drug Administration shall conduct interviews with their main responsible persons.

The drug supervision and management departments and local people's governments of the provinces, autonomous regions, and municipalities directly under the central government interviewed shall immediately take measures to rectify the drug supervision and management work.

The interview and rectification situation should be included in the evaluation and assessment records of drug supervision and management work of the drug supervision and management departments of provinces, autonomous regions, and municipalities directly under the central government, as well as local people's governments.

Chapter 5 Legal Liability

Article 68: Penalties shall be imposed in accordance with Article 115 of the Drug Administration Law in any of the following circumstances:

（1） Holders of drug marketing licenses and drug production enterprises who change their production address or scope without approval;

（2） The drug production license is still in production after its expiration date.

Article 69: If the holder of the drug marketing license and the drug production enterprise fail to produce according to the requirements of the drug production quality management standards and have one of the following circumstances, which falls under the serious circumstances stipulated in Article 126 of the Drug Administration Law, they shall be punished in accordance with the law:

（1） Without a dedicated quality manager independently responsible for drug quality management and supervising the implementation of quality management standards;

（2） The holder of the drug marketing license does not have a dedicated quality authorized person to fulfill the responsibility of drug marketing release;

（3） The drug production enterprise has not equipped a dedicated quality authorized person to fulfill the responsibility of drug release from the factory;

（4） The quality management system cannot operate normally, and the records and data of drug production process control and quality control are not authentic;

（5） Failure to take timely and effective risk control measures for identified risks, resulting in inability to ensure product quality;

（6） Other serious violations of drug production quality management standards.

Article 70: If the production enterprises and suppliers of excipients, packaging materials and containers that come into direct contact with drugs fail to comply with relevant requirements such as quality management standards formulated by the National Drug Administration and cannot ensure the continuous compliance of the quality assurance system, the drug regulatory departments of the provinces, autonomous regions, and municipalities directly under the Central Government where they are located shall impose penalties in accordance with Article 126 of the Drug Administration Law.

Article 71: If the holder of a drug marketing license or a drug production enterprise falls under any of the following circumstances, the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where they are located shall impose a fine of not less than 10000 yuan but not more than 30000 yuan:

（1） The enterprise name, address (business premises), and legal representative fail to handle registration changes in accordance with regulations;

（2） Failure to conduct annual health checks and establish health records for personnel who come into direct contact with drugs in accordance with regulations;

（3） Failure to report production stoppage of drugs listed in the list of shortage drugs that have been implemented in accordance with regulations.

Article 72: If a drug regulatory department commits one of the following acts, the directly responsible supervisory personnel and other directly responsible personnel shall be punished in accordance with Article 149 of the Drug Administration Law:

（1） Concealing, falsely reporting, delaying, or failing to report drug safety incidents;

（2） Failure to promptly investigate and punish drug safety violations discovered;

（3） Failure to timely identify systemic risks to drug safety, or failure to promptly eliminate potential drug safety hazards within the supervision and management area, resulting in serious impacts;

（4） Failure to fulfill drug supervision and management responsibilities, resulting in serious adverse effects or significant losses.

Chapter 6 Supplementary Provisions

Article 73: The time limit specified in these Measures shall be calculated on working days. The time required for technical review and evaluation, on-site inspection, and enterprise rectification in the drug production license is not included in the deadline.

Article 74 Site management documents refer to the summary documents of drug production activities prepared by drug production enterprises, which are a part of the quality management document system of drug production enterprises. The requirements for site management documents will be formulated separately.

The production sites of raw materials, excipients, packaging materials and containers that come into direct contact with drugs, as well as overseas production sites, which have been approved or reviewed and approved by relevant parties, will be assigned a unified code.

Article 75: A warning letter refers to a letter issued by the drug regulatory department in drug supervision and management activities, in accordance with the law, if there is evidence to prove that there may be safety hazards. The warning letter should indicate the existence of defects, issues, and rectification requirements.

Article 76: The format of the drug production license number is "province abbreviation+four digit year number+four digit sequential number". If the enterprise changes its name or issues a new license, the original drug production license number will remain unchanged.

The separation of enterprises involves adding a new number while retaining the original drug production license number. Enterprise merger, retaining one original drug production license number.

Article 77: The classification code is a string of English letters used for statistical classification of the production scope within the license. Capital letters are used to classify drug marketing license holders and product types, including: A represents self produced drug marketing license holders, B represents commissioned drug marketing license holders, C represents commissioned drug production enterprises, and D represents raw material drug production enterprises; The lowercase letters are used to distinguish the properties of preparations. h represents chemical medicine, z represents traditional Chinese patent medicines and simple preparations, s represents biological products, d represents in vitro diagnostic reagents managed by drugs, y represents Chinese herbal decoction pieces, q represents medical gas, t represents special drugs, and x represents others.

Article 78: The production scope of a drug production license shall be filled out in accordance with the General Principles of Preparation in the Pharmacopoeia of the People's Republic of China and other national drug standards.

Article 79 If there are other provisions in relevant national laws and regulations regarding the production of vaccines, blood products, anesthetic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, precursor chemicals for pharmaceuticals, etc., such provisions shall prevail.

Article 80: Vaccines exported shall comply with the standards or contractual requirements of the importing country (region).

Article 81: These measures shall come into effect from July 1, 2020. On August 5, 2004, the "Measures for the Supervision and Administration of Drug Production" promulgated by Order No. 14 of the former State Food and Drug Administration shall be abolished simultaneously.