Xinhua News Agency, Beijing, October 8th (Xinhua) - Recently, the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council issued the "Opinions on Deepening the Reform of the Evaluation and Approval System and Encouraging Innovation in Pharmaceutical and Medical Devices", and issued a notice requiring all regions and departments to conscientiously implement them based on actual conditions.

The full text of the "Opinions on Deepening the Reform of the Evaluation and Approval System to Encourage Innovation in Pharmaceutical and Medical Devices" is as follows.

Currently, China's pharmaceutical and medical device industry is developing rapidly, innovation and entrepreneurship are in the ascendant, and the reform of the review and approval system is continuously advancing. However, overall, China's pharmaceutical and medical device technology innovation support is insufficient, and there is a gap between the quality of listed products and the international advanced level. In order to promote the structural adjustment and technological innovation of the pharmaceutical and medical device industry, improve industrial competitiveness, and meet the clinical needs of the public, the following opinions are proposed to deepen the reform of the review and approval system and encourage innovation in pharmaceutical and medical devices.

1、 Reforming Clinical Trial Management

（1） The qualification recognition of clinical trial institutions shall be subject to filing management. Institutions that meet the conditions for clinical trials can accept the commission of drug and medical device registration applicants to conduct clinical trials after registering and filing on the designated website of the food and drug regulatory department. The main researchers in clinical trials should have senior professional titles and have participated in more than three clinical trials. The registration applicant can hire a third party to evaluate and certify whether the clinical trial institution meets the conditions. Encourage social forces to invest in establishing clinical trial institutions. The management regulations for clinical trial institutions shall be formulated by the Food and Drug Administration in conjunction with the National Health and Family Planning Commission.

（2） Support clinical trial institutions and personnel in conducting clinical trials. Support medical institutions, medical research institutions, and pharmaceutical universities in conducting clinical trials, and include the evaluation of clinical trial conditions and capabilities in the level evaluation of medical institutions. Establish a separate evaluation and assessment system for medical institutions conducting clinical trials. Beds used only for clinical trials are not included in the total hospital beds of medical institutions, and there are no evaluation indicators such as bed efficiency, turnover rate, and utilization rate specified. Encourage medical institutions to establish dedicated clinical trial departments and equip them with professional clinical trial researchers. Improve the incentive mechanism for unit performance salary distribution to ensure the income level of clinical trial researchers. Encourage clinical doctors to participate in pharmaceutical and medical device technology innovation activities, and treat clinical trial researchers equally in terms of job promotion, title promotion, and other aspects. Allow overseas enterprises and research institutions to conduct clinical trials of new drugs simultaneously in China in accordance with the law.

（3） Improve the mechanism of the ethics committee. Clinical trials should comply with ethical and ethical standards, ensuring that subjects are informed of sufficient trial information before voluntary participation, understand and sign informed consent forms, and protect the safety, health, and rights of subjects. Clinical trial institutions should establish an ethics committee responsible for reviewing their clinical trial plans, reviewing and supervising the qualifications of clinical trial researchers, supervising the progress of clinical trials, and accepting inspections from regulatory authorities. Each region may establish regional ethics committees as needed to guide the ethical review work of clinical trial institutions, and may accept commissions from institutions or registration applicants that do not meet the ethical review requirements to conduct ethical reviews of clinical trial plans, and supervise the progress of clinical trials. Departments such as health and family planning, traditional Chinese medicine management, and food and drug supervision should strengthen their management guidance and business supervision of the work of the ethics committee.

（4） Improve the efficiency of ethical review. Before submitting a clinical trial application, the registration applicant should first submit the clinical trial plan to the ethics committee of the clinical trial institution for review and approval. For multicenter clinical trials conducted within China, after ethical review by the clinical trial leader unit, other member units should recognize the review conclusion of the leader unit and no longer repeat the review. The National Clinical Medical Research Center and clinical trial institutions that undertake major national scientific and technological projects and support national key research and development plans should integrate resources to establish a unified ethical review platform and gradually promote ethical review and mutual recognition.

（5） Optimize the clinical trial approval process. Establish and improve a communication and exchange mechanism between registration applicants and evaluation institutions. Before accepting drug clinical trials and medical device clinical trial applications that require approval, the evaluation institution should hold a meeting with the registration applicant to communicate and provide opinions and suggestions. Within a certain period of time after accepting the clinical trial application, if the food and drug regulatory department does not provide a negative or questioning opinion, it shall be deemed as agreement. The registration applicant may carry out the clinical trial according to the submitted plan. During the clinical trial, if there are changes to the clinical trial protocol, major pharmaceutical changes, or non clinical research safety issues, the registration applicant shall promptly report the changes to the evaluation institution; If safety and other risks are found, the clinical trial protocol should be modified, suspended or terminated in a timely manner. The applicant for drug registration may issue an inspection report on clinical trial samples on their own or entrust an inspection agency, and submit it together with the samples to the drug review agency, ensuring that the actual samples used in the clinical trial are consistent with the submitted samples. Optimize the approval process for human genetic resource activities involving international cooperation in clinical trials, and accelerate the process of clinical trials.

（6） Accept overseas clinical trial data. Clinical trial data obtained from multiple centers overseas that meet the relevant requirements for drug and medical device registration in China can be used for application for registration in China. For drugs and medical devices that are first applied for marketing in China, registration applicants should provide clinical trial data on whether there are racial differences.

（7） Support for expanded clinical trials. For drugs and medical devices that are undergoing clinical trials to treat diseases that pose a serious threat to life and do not have effective treatment methods, if they may benefit from initial observation and meet ethical requirements, they can be used for other patients in institutions conducting clinical trials with informed consent, and their safety data can be used for registration applications.

（8） Serious investigation and punishment of data fraud. The signatory of the clinical trial commission agreement and the clinical trial researcher are the first responsible persons for the clinical trial data, and must bear legal responsibility for the reliability of the clinical trial data. Establish an examination mode based on risk and evaluation needs, strengthen on-site and causal examinations for non clinical research and clinical trials, and make the examination results publicly available to the society. If the inspection is not passed, the relevant data will not be accepted; If there are authenticity issues, a timely investigation should be filed, and the responsible persons of relevant non clinical research institutions and clinical trial institutions, those responsible for providing false reports, registration applicants, and contract research organizations should be held accountable in accordance with the law; Those who refuse, evade, or obstruct inspection shall be given heavier punishment in accordance with the law. If the registration applicant proactively discovers problems and reports them in a timely manner, they may be exempted from punishment at their discretion.

2、 Accelerate listing review and approval

（9） Accelerate the review and approval of urgently needed drugs and medical devices in clinical practice. For drugs and medical devices that are urgently needed for the treatment of diseases that pose a serious threat to life and do not have effective treatment methods, as well as public health, if early and mid-term clinical trial indicators show efficacy and can predict their clinical value, they can be approved for listing with conditions attached. Enterprises should develop risk control plans and conduct research as required. Encourage the research and development of new drugs and innovative medical devices, and prioritize the review and approval of new drugs and innovative medical devices supported by major national science and technology projects and national key research and development plans, as well as those conducted by the National Clinical Medical Research Center and recognized by the central management department.

（10） Support the research and development of rare disease treatment drugs and medical devices. The National Health and Family Planning Commission or relevant industry associations entrusted by it shall publish a list of rare diseases and establish a registration system for rare disease patients. Applicants for the registration of rare disease treatment drugs and medical devices can apply for exemption from clinical trials. For rare disease treatment drugs and medical devices that have been approved for listing overseas, approval for listing may be granted with conditions attached. Enterprises should develop risk control plans and conduct research as required.

（11） Strictly review and approve drug injections. Strictly control the conversion of oral preparations to injection preparations. If oral preparations can meet clinical needs, injection preparations are not approved for marketing. Strictly control the conversion of intramuscular injection preparations to intravenous injection preparations. If intramuscular injection preparations can meet clinical needs, intravenous injection preparations are not approved for marketing. The application for mutual modification of dosage forms between large capacity injections, small capacity injections, and sterile powder injections for injection shall not be approved if there is no obvious clinical advantage.

（12） Implement approval for the association of drugs with pharmaceutical raw materials and packaging materials. The raw materials, pharmaceutical excipients, and packaging materials shall be reviewed and approved together with the drug registration application, and no approval number for raw materials shall be issued. The raw materials, pharmaceutical excipients, and packaging materials and their quality standards that have been reviewed and approved by related parties shall be publicly displayed on designated platforms for relevant enterprises to choose from. The holder of the drug marketing license is responsible for the quality of the raw materials, medicinal excipients, and packaging materials used in the production of preparations.

（13） Support the inheritance and innovation of traditional Chinese medicine. Establish and improve a registration management system and technical evaluation system that conforms to the characteristics of traditional Chinese medicine, and handle the relationship between maintaining the traditional advantages of traditional Chinese medicine and the requirements of modern drug research and development. Innovative traditional Chinese medicine should highlight new characteristics of therapeutic effects; Improved new drugs of traditional Chinese medicine should reflect the advantages of clinical application; Classic and famous traditional Chinese medicine, reviewed and approved according to simplified standards; Natural drugs are reviewed and approved according to modern medical standards. To enhance the clinical research capabilities of traditional Chinese medicine, application for registration of traditional Chinese medicine requires submission of market value and resource evaluation materials, highlighting the clinical value orientation and promoting sustainable resource utilization. Encourage the use of modern science and technology to research and develop traditional traditional Chinese patent medicines and simple preparations, encourage the development of new Chinese medicine by giving play to the advantages of traditional Chinese medicine dosage forms, and strengthen the quality control of Chinese medicine.

（14） Establish a priority review and approval system for compulsory patent licensing drugs. In cases where public health is under significant threat, drug registration applications that have obtained compulsory licensing will be given priority review and approval. The situation of significant threat to public health and the procedure for initiating compulsory licensing shall be formulated by the National Health and Family Planning Commission in conjunction with relevant departments.

3、 Promoting drug innovation and the development of generic drugs

（15） Establish a list of listed drugs. Newly approved drugs or drugs that have passed the quality and efficacy consistency evaluation of generic drugs shall be included in the Chinese listed drug catalog, indicating the attributes of innovative drugs, improved new drugs, and generic drugs that are consistent with the quality and efficacy of the original research drugs, as well as information such as effective ingredients, dosage forms, specifications, marketing license holders, patent rights obtained, and experimental data protection period.

（16） Explore the establishment of a drug patent linkage system. To protect the legitimate rights and interests of patent holders, reduce the risk of generic drug patent infringement, encourage the development of generic drugs, and explore the establishment of a drug review and approval and drug patent linkage system. When submitting a registration application for a drug, the applicant for drug registration should explain the relevant patents involved and their ownership status, and inform the relevant drug patent holder within the prescribed period. If there is a dispute over patent rights, the parties may file a lawsuit with the court, and the drug technical evaluation shall not be suspended during this period. For drugs that have passed the technical review, the food and drug regulatory department shall make a decision on whether to approve the listing based on the effective judgment, ruling or mediation letter of the court; If no effective judgment, ruling or mediation agreement has been obtained after a certain period of time, the food and drug regulatory authority may approve the listing.

（17） Pilot the compensation system for drug patent term. Select some new drugs for pilot testing, and provide appropriate patent period compensation for delays in marketing due to clinical trials and review and approval.

（18） Improve and implement the drug trial data protection system. When submitting a registration application, drug registration applicants can also submit an application for experimental data protection. For innovative drugs, rare disease treatment drugs, children's specialized drugs, innovative therapeutic biological products, and self obtained and undisclosed experimental data and other data submitted by successful patent challenge drug registration applicants, a certain data protection period shall be granted. The data protection period is calculated from the date of drug approval for marketing. During the data protection period, other applicants shall not be allowed to apply for the same variety of product listing, except for data obtained by the applicant themselves or with the consent of the applicant who has obtained the listing license.

（19） Promote the production of generic drugs. Adhere to encouraging innovation and promoting the production of generic drugs, reducing the burden of medication, regularly publish a list of drugs with expired, terminated, invalid patent rights, and no generic application, guide the research and development and production of generic drugs, and improve public access to medication. Improve the guiding principles of relevant research and evaluation techniques, and support the imitation of biologically similar drugs and clinically valuable pharmaceutical device combinations. Accelerate the evaluation of the quality and efficacy consistency of generic drugs.

（20） Give full play to the innovative role of enterprises. Encourage pharmaceutical and medical device enterprises to increase research and development investment, strengthen the research and development of new products and continue to research products that have already been launched, and continuously improve production processes. Allow research institutions and researchers to apply for clinical trials while assuming relevant legal responsibilities. For those who use national financial appropriations to carry out research and development of new drugs and innovative medical devices, as well as related technology research, and transform them into professional scientific and technological achievements, the unit may stipulate or agree with scientific researchers on the methods, amounts, and time limits of rewards and rewards, mobilize the enthusiasm of scientific researchers to participate, and promote the transfer and transformation of scientific and technological achievements.

（21） Support the clinical application of new drugs. Improve the dynamic adjustment mechanism of the medical insurance drug catalog, explore the establishment of a negotiation mechanism for medical insurance drug payment standards, timely include new drugs in the basic medical insurance payment scope according to regulations, and support the research and development of new drugs. According to the needs of disease prevention and control, new drugs can be included in the scope of centralized drug procurement in public hospitals in a timely manner. Encourage medical institutions to prioritize the procurement and use of new drugs with clear therapeutic effects and reasonable prices.

4、 Strengthen the full lifecycle management of drugs and medical devices

（22） Promote the comprehensive implementation of the listing permit holder system. Timely summarize the pilot experience of the drug marketing license holder system, promote the revision of the Drug Management Law, and strive to promote it nationwide as soon as possible. Allow medical device research and development institutions and researchers to apply for medical device marketing licenses.

（23） Implement the legal responsibilities of listing permit holders. The holder of the drug marketing license shall bear full legal responsibility for preclinical research, clinical trials, production and manufacturing, sales and distribution, adverse reaction reports, etc. of the drug, ensure that the submitted research materials and clinical trial data are true, complete, and traceable, ensure that the production process is consistent with the approved process and that the production process continues to comply, ensure that the quality of each batch of drugs sold is consistent with the declared sample, and ensure that continuous research is conducted on the listed drugs, Timely report any adverse reactions that occur, evaluate the risk situation, and propose improvement measures.

The holder of the medical device marketing license shall bear full legal responsibility for the design and development, clinical trials, production and manufacturing, sales and distribution, adverse event reports, etc. of the medical device, ensure the authenticity, completeness, and traceability of the submitted research and clinical trial data, ensure continuous research on the listed medical device, timely report any adverse events that occur, evaluate the risk situation, and propose improvement measures.

Enterprises, institutions, and individuals entrusted by the holder of the marketing license for pharmaceutical and medical devices to conduct research and development, clinical trials, production and manufacturing, sales and distribution must bear the responsibilities stipulated by laws and regulations and agreed upon in the agreement.

（24） Establish a system for listing permit holders to directly report adverse reactions and events. The holder of the listing permit shall bear the main responsibility for reporting adverse reactions and adverse events, and those who conceal or delay the reporting shall be punished severely in accordance with the law. The food and drug regulatory authorities should investigate and analyze the reported adverse reactions and events, and order the marketing license holders to take measures such as suspending sales, recalling, and improving quality control as appropriate.

（25） Conduct re evaluation of drug injections. Based on the progress of pharmaceutical science, we will conduct a re evaluation of drug injections that have already been marketed, striving to complete them in approximately 5 to 10 years. The holder of the marketing license must conduct a comprehensive analysis of the research situation at the time of approval for marketing, as well as the ongoing research situation after marketing, to conduct research on the product ingredients, mechanism of action, and clinical efficacy, and to evaluate its safety, effectiveness, and quality controllability. Through re evaluation, enjoy the relevant incentive policies for evaluating the consistency of generic drug quality and efficacy.

（26） Improve the re evaluation system for medical devices. The holder of the marketing license must actively conduct a re evaluation of the listed medical devices based on scientific progress and adverse event assessment results. If the re evaluation finds that the product cannot guarantee safety and effectiveness, the marketing license holder should promptly apply for the cancellation of the marketing license; If the re evaluation results are concealed and the application for cancellation is not made, the listing permit shall be revoked and investigated in accordance with the law.

（27） Standardize the academic promotion of drugs. The holder of the drug marketing license must record the list of pharmaceutical representatives on the website designated by the food and drug regulatory department and make it publicly available to the public. Medical representatives are responsible for academic promotion of drugs, introducing drug knowledge to medical staff, and listening to opinions and suggestions on clinical use. The academic promotion activities of medical representatives should be conducted openly and recorded in the designated department of the medical institution. It is prohibited for pharmaceutical representatives to undertake drug sales tasks, and it is prohibited to provide the quantity of drug prescriptions issued by doctors to pharmaceutical representatives or relevant enterprise personnel. Medical representatives who mislead doctors into using drugs or conceal adverse drug reactions should be investigated and dealt with seriously; Those who engage in drug trading activities under the name of pharmaceutical representatives shall be investigated and punished as illegal drug trading.

5、 Enhance technical support capabilities

（28） Improve the technical review system. Establish a technical review system led by review and supported by inspection and inspection, improve the review project manager system, the communication system between review institutions and registration applicants, and the expert consultation committee system, strengthen internal management, and standardize the review process. Establish a drug review team mainly composed of clinical medical professionals, including professionals in pharmacy, pharmacology, toxicology, statistics, etc., responsible for the review of new drugs. Establish a medical device review team composed of professionals in clinical medicine, clinical diagnosis, machinery, electronics, materials, biomedical engineering, and other fields, responsible for reviewing innovative medical devices. Except for technical secrets such as production processes, all evaluation conclusions and basis are publicly available and subject to social supervision. Unify the evaluation standards for Class II medical devices and gradually achieve national unified evaluation.

（29） Implement the confidentiality responsibilities of relevant staff. Personnel involved in the acceptance and review, review and approval, inspection and inspection of pharmaceutical and medical devices shall have the obligation to keep confidential the technical secrets and test data submitted by the registration applicant. Those who violate confidentiality obligations shall be held accountable in accordance with the law and discipline, and the results of the handling shall be made public to the public; Those suspected of committing crimes shall be transferred to judicial authorities for criminal responsibility. Improve the management of registration application materials to ensure traceability of access and copying.

（30） Strengthen the construction of evaluation and inspection capabilities. Incorporate drug and medical device evaluation into the scope of government procurement services and provide standardized and efficient evaluation services. Accelerate the informatization construction of drug and medical device review and approval, formulate technical requirements for electronic submission of registration applications, improve the electronic general technical document system, and gradually achieve electronic submission and review and approval of various registration applications. Establish a record of the variety of marketed drugs and medical devices.

（31） Implement full process inspection responsibilities. The research and development process of pharmaceutical and medical devices, as well as the implementation of non clinical research quality management standards, clinical trial quality management standards, and clinical trial quality management standards for medical devices, shall be inspected by the national food and drug regulatory department. The production process and implementation of quality management standards for pharmaceutical and medical devices shall be inspected by food and drug regulatory departments at or above the provincial level. The operation process and implementation of quality management standards for pharmaceutical and medical devices shall be inspected by the food and drug regulatory departments at the city and county levels. If problems are found during inspection, they should be investigated and dealt with in accordance with the law and regulations, and risk control measures should be taken in a timely manner; Those suspected of committing crimes shall be transferred to judicial authorities for criminal responsibility. Promote the punishment of illegal acts to individuals, and make the inspection and punishment results publicly available to society.

（32） Build a professional team of inspectors. Relying on existing resources to accelerate the construction of the inspector team, forming a professional inspector team with full-time inspectors as the main body and part-time inspectors as supplements. Implement a hierarchical management system for inspectors, strengthen training for inspectors, equip inspection equipment, and enhance inspection capabilities and levels.

（33） Strengthen international cooperation. Deepen policy and technical exchanges on drug and medical device regulation on multiple and bilateral levels, actively participate in the formulation and revision of international rules and standards, and promote the gradual realization of international sharing of evaluation, inspection, testing standards and results.

6、 Strengthen organizational implementation

（34） Strengthen organizational leadership. All regions and relevant departments should fully understand the importance of deepening the reform of the review and approval system to encourage innovation in pharmaceutical and medical devices, attach great importance to the reform and innovation of pharmaceutical and medical device review and approval, and support it as an important part of building an innovative country and promoting the development of high-tech industries. They should strengthen overall coordination, refine implementation plans, improve work mechanisms, and effectively implement tasks. Adhere to the use of rule of law thinking and methods to promote reform, continuously improve relevant laws, regulations, and institutional systems. If the reform measures involve legal modifications or require corresponding authorization, they shall be submitted for legal modifications according to procedures or authorized by legislative organs before implementation.

（35） Strengthen collaboration and cooperation. Give full play to the role of the inter ministerial joint meeting system for the reform of the drug and medical device review and approval system, and promptly study and solve the contradictions and problems encountered in the reform. The national food and drug regulatory authorities should play a leading role, focus on the specific implementation of reforms, and coordinate the implementation of tasks. All relevant departments should perform their duties in accordance with the law, divide their work and collaborate, and form a joint force for reform. The development and reform department should support the development of pharmaceutical high-tech products, and include the construction of clinical trial institutions in the important content of medical institution construction and development. The science and technology department should strengthen the planning and guidance for the development of pharmaceutical technology, and focus on the implementation of science and technology plans (special projects, funds) related to the research and development of new drugs and innovative medical devices. The industrial and information technology departments should strengthen the development planning and guidance of the pharmaceutical industry, and strengthen the guarantee of clinical drug production. The financial department should ensure the funding required for the review, approval, inspection and inspection of drugs and medical devices. The human resources and social security department should do a good job in supporting the development of new drugs through medical insurance policies. The health and family planning department should strengthen guidance on the construction of clinical trial institutions, strengthen the management of ethics committees, and train clinical trial researchers. The intellectual property department should do a good job in protecting the intellectual property rights of drugs and medical devices related to patents. The management department of traditional Chinese medicine should do a good job in the innovation of traditional Chinese medicine.

（36） Do a good job of promoting and explaining. Positively promoting the importance of encouraging innovation in pharmaceutical and medical devices, strengthening the interpretation of important policies and measures for the reform of the review and approval system, timely answering hot issues of concern to all sectors of society, actively responding to social concerns, reasonably guiding expectations of all parties, and creating a good public opinion atmosphere for the implementation of the reform.