General Office of the State Council on comprehensively Deepening the reform of drug and medical device supervision

Opinions on promoting high-quality development of the pharmaceutical industry

People's governments of provinces, autonomous regions and municipalities directly under the Central Government, ministries and commissions under The State Council:

I. General requirements

Create an innovation ecology with global competitiveness, promote China's leap from a pharmaceutical power to a pharmaceutical power, and better meet the needs of the people for high-quality medicines and medical devices.

By 2027, the regulatory laws and regulations for drugs and medical devices will be more perfect, the regulatory system, regulatory mechanism and regulatory methods will better meet the needs of pharmaceutical innovation and high-quality development of the industry, the quality and efficiency of the review and approval of innovative drugs and medical devices will be significantly improved, the supervision of the whole life cycle will be significantly strengthened, and the quality and safety level will be comprehensively improved. Establish a regulatory system that is compatible with pharmaceutical innovation and industrial development. By 2035, the quality, safety, effectiveness and accessibility of pharmaceutical and medical devices will be fully guaranteed, the pharmaceutical industry will have stronger innovation and creativity and global competitiveness, and the regulatory modernization will be basically realized.

Second, increase support for research and development and innovation of pharmaceutical medical devices

1. Improving the review and approval mechanism to fully support major innovations. In accordance with the requirements of "advance intervention, one enterprise, one policy, whole-process guidance, research and review linkage", the review and approval resources are more inclined to the key innovative drugs and medical devices that are urgently needed in clinic, strengthen communication and exchanges in the whole process of clinical trials, registration and declaration, verification and inspection, review and approval, and provide personalized guidance. (State Food and Drug Administration)

   
   

(2) Increase support for TCM R&D and innovation. We will improve the evidence system of TCM characteristics evaluation, which combines TCM theory, human experience and clinical trials, and establish a mechanism for medical institutions to collect and collate human experience data in a standardized manner. Improve the supervision system of traditional Chinese medicine that conforms to the characteristics of traditional Chinese medicine. We will actively support famous old Chinese medicine prescriptions and medical institutions to transform traditional Chinese medicine preparations into new medicines. Encourage the use of new technologies, new processes and new dosage forms in line with product characteristics to improve the listed Chinese medicine varieties. (The State Food and Drug Administration takes the lead, and the Ministry of Industry and Information Technology, the National Health Commission and the State Administration of Traditional Chinese Medicine are responsible according to their respective responsibilities)

(3) Give play to the leading role of standards in pharmaceutical and medical device innovation. Further promote the national action plan to improve the standards of pharmaceutical and medical devices, and actively promote the standard research and transformation of new technologies, new methods, and new tools. We will improve the national drug standards database and publish and update the online version of the Chinese Pharmacopoeia in a timely manner. Optimize the standard system of medical devices, and study and establish standardization technical organizations for cutting-edge medical devices such as artificial intelligence and medical robots. Strengthen the formulation of TCM medical device standards. (The State Food and Drug Administration takes the lead, and the Ministry of Industry and Information Technology, the National Health Commission, the General Administration of Market Regulation and the State Administration of Traditional Chinese Medicine are responsible for the division of responsibilities)

(4) Improve the intellectual property protection system for drugs and medical devices. When some drugs are approved for listing, a certain period of data protection shall be given to the test data and other data obtained and not disclosed submitted by the registration applicant. Certain market exclusivity period is granted to qualified rare disease drugs, children's drugs, the first chemical generic drugs and exclusive Chinese medicine varieties. Accelerate the patent layout of original achievements of drugs and medical devices, and improve the quality of patents and the efficiency of transformation and application. (The State Intellectual Property Office and the State Food and Drug Administration shall be responsible according to the division of responsibilities)

(5) Actively supporting the promotion and use of innovative drugs and medical devices. Strengthen the clinical comprehensive evaluation of innovative drugs, and strengthen the analysis and application of evaluation results. To study and trial the self-evaluation of newly listed drug enterprises based on pharmaceutical and clinical value, and optimize the online listing service of newly listed drugs. Adhere to the "basic" function of basic medical insurance, improve the mechanism for adjusting the medical insurance drug catalog, study and standardize the medical insurance medical consumables catalog and medical service project catalog, and include qualified innovative drugs and medical devices in the medical insurance payment scope according to procedures, and encourage medical institutions to purchase and use them. We will improve the multi-tiered medical security system and increase the ability to pay for innovative drugs. Actively disseminate accurate and comprehensive information on innovative drugs and medical devices to the public. (The Ministry of Industry and Information Technology, the National Health Commission, the State Administration of Market Regulation, the State Medical Insurance Administration, the State Food and Drug Administration shall be responsible for the division of responsibilities)

Third, improve the quality and efficiency of drug and medical device review and approval

(6) Strengthen the pre-registration guidance of drugs and medical devices. Shorten the waiting time for clinical trial communication of urgently needed innovative drugs. Carry out multi-channel and multi-level communication, do a good job of "drug examination cloud classroom" and "device examination cloud classroom", give play to the role of the review and inspection branch center and the linkage mechanism of medical device innovation service, and strengthen the publicity and interpretation of the registration and declaration rules. (State Food and Drug Administration)

(7) Accelerate the approval and listing of urgently needed drugs and medical devices. For clinically urgently needed cell and gene therapy drugs, overseas listed drugs, combined vaccines, radioactive drugs, rare and endangered medicinal materials substitutes declared varieties, as well as medical robots, brain-computer interface equipment, radiation therapy equipment, medical imaging equipment, innovative traditional Chinese medicine diagnosis and treatment equipment and high-end medical equipment for transplant intervention, priority review and approval. (The National Health Commission and the State Food and Drug Administration shall be responsible according to their respective responsibilities)

(8) Optimize the clinical trial review and approval mechanism. After the provincial drug regulatory department submitted an application and the State Food and Drug Administration agreed to it, the pilot program for optimizing the review and approval of innovative drug clinical trials was carried out in some areas, and the review and approval time limit was shortened from 60 working days to 30 working days. The time limit for the review and approval of clinical trials of medical devices has been shortened from 60 working days to 30 working days. Optimize the bioequivalence test filing mechanism. (Led by the State Food and Drug Administration, with the cooperation of provincial people's governments in pilot areas)

(9) Optimize the review and approval of supplementary drug applications. After the provincial drug regulatory department submitted an application and the State Food and Drug Administration agreed to it, the pilot reform to optimize the review and approval process for supplementary drug applications was carried out in some areas, and the time limit for the review of supplementary applications requiring verification and inspection was shortened from 200 working days to 60 working days. Optimize the management of apis, and the subject of API registration can be changed according to law. (Led by the State Food and Drug Administration, with the cooperation of provincial people's governments in pilot areas)

(10) Optimize the registration and inspection of drugs and medical devices. The amount of each batch of drug registration inspection, batch issuance inspection of biological products and import drug customs clearance inspection is reduced from 3 times to 2 times of the amount of all tests. Smooth the green channel for the priority inspection of innovative drugs and medical devices, and implement instant inspection of clinically urgent drugs and medical devices. (State Food and Drug Administration)

(11) Speeding up the review and approval of drugs and medical devices for rare diseases. Exemption of clinical trials for qualified innovative drugs and medical devices for rare diseases. The registration test batch of drugs for rare diseases was reduced from 3 batches to 1 batch, and the dosage of each batch was reduced from 3 times the amount of the whole test to 2 times. Make overall arrangements for registration verification and post-market inspection of imported rare disease drugs based on product risks, and shorten the waiting time for overseas verification. Explore the specific medical institutions to first import clinical urgent rare disease drugs and medical devices that are not registered and listed in China. National medical centers are encouraged to strengthen the allocation and use of drugs and medical devices for rare diseases. High-level medical institutions are encouraged to develop and use diagnostic reagents for rare diseases that have not yet been marketed with the same varieties in China. (The National Health Commission and the State Food and Drug Administration shall be responsible according to their respective responsibilities)

Fourth, improve the compliance level of the pharmaceutical industry with efficient and strict supervision

(12) Promoting the authorization of batch issuance of biological products (vaccines). On the basis of fully assessing the risks, gradually expand the scope of inspection and testing institutions and varieties of provincial drug regulatory departments authorized to implement the batch issuance of biological products (vaccines). The time limit for batch issuance of seasonal influenza vaccines and other varieties has been reduced to less than 45 working days. (Led by the State Food and Drug Administration, with the cooperation of the provincial people's governments of relevant regions)

(13) Promoting the quality improvement of generic drugs. Optimize the working mechanism of generic drug review and verification, and increase dynamic inspection before approval based on product risks. We will strengthen supervision over commissioned research and development, commissioned production and post-listing changes, and support enterprises with high information technology levels, strong quality assurance and risk prevention and control capabilities to accept commissions. The evaluation of the consistency of the quality and efficacy of generic drugs is gradually extended to the dosage forms such as eye drops, patches and sprays. (State Food and Drug Administration)

(14) Promote the informatization of the production and inspection process of pharmaceutical enterprises. Promote the deep integration of a new generation of information technology and the pharmaceutical industry chain, and support the digital intelligent transformation of pharmaceutical and medical device manufacturers. Strict supervision of vaccine production enterprises to fully implement the production inspection process information requirements. Promote the information-based transformation of blood product production in batches, and promote the establishment of an information-based blood product management system covering the whole process from pulp collection, factory entry to production and testing. (The Ministry of Industry and Information Technology, the National Health Commission and the State Food and Drug Administration shall be responsible according to the division of responsibilities)

(15) Improve the efficiency of supervision and inspection of drugs and medical devices. Strengthen the quality and safety warning education for enterprises, and urge enterprises to comprehensively improve the quality management system. Determine the inspection frequency reasonably according to the enterprise and product risk level to reduce repeated inspections. Encourage the national and provincial drug regulatory departments to cooperate with the production enterprises involved in the registration of on-site inspection and production quality management standards compliance inspection. Enterprises producing Class II and Class III medical devices that produce Class I medical devices at the same time shall be subject to combined inspection. (State Food and Drug Administration)

(16) Strengthen the vigilance of innovative drugs and medical devices. To guide and urge innovative drug marketing authorization holders to establish and improve pharmacovigilance system, actively monitor, report and analyze adverse reactions, and continue to carry out post-marketing research on innovative drugs. Improve the monitoring platform for adverse drug reactions and adverse events of medical devices based on the risk characteristics of innovative drugs and medical devices. Active post-marketing monitoring of innovative drugs and medical devices will be strengthened. (The National Health Commission and the State Food and Drug Administration shall be responsible according to their respective responsibilities)

(17) Improving the quality and effectiveness of supervision on new forms of pharmaceutical circulation. Establish a co-governance alliance for drug and medical device online sales security risks, and consolidate the responsibility of third-party platforms for online transactions. Support wholesale enterprises to effectively integrate storage resources and transportation resources, and build a multi-warehouse collaborative logistics management model. Optimize the licensing process and increase retail chain rates. TCM decoction pieces prepared in accordance with provincial processing standards can be sold across provinces according to regulations, and TCM formula particles produced in accordance with national drug standards can be directly sold across provinces. (The State Food and Drug Administration takes the lead, and the Ministry of Commerce, the National Health Commission, the General Administration of Market Regulation and the State Administration of Traditional Chinese Medicine are responsible according to their responsibilities)

Fifth, support the pharmaceutical industry to expand opening-up and cooperation

18. Promoting the translation and implementation of common international regulatory rules. Continue to promote the coordination of technical requirements for drug review with the rules of the International Technical Coordination Committee for Human Drugs, support drug clinical trial institutions to participate in the early clinical research and development of innovative drugs, support the implementation of international multi-center clinical trials, and promote the synchronous research and development, synchronous declaration, synchronous review, and synchronous listing of global drugs in China. Actively promote the translation and implementation of the technical guidelines of the International Medical Device Regulatory Forum and the Global Medical Device Regulatory Coordination Committee in China. (The National Health Commission and the State Food and Drug Administration shall be responsible according to their respective responsibilities)

(19) Exploring segmented production models for biological products. Provincial drug regulatory departments to apply, the State Food and Drug Administration agreed to carry out in some areas of the production process, facilities and equipment have special requirements of the segmented production of biological products pilot, take the lead in promoting antibody coupled drugs, multi-valent vaccines and other segmented production. Support qualified overseas drug marketing authorization holders to carry out cross-border segmented production in the form of self-built production capacity or commissioned production under a unified drug quality management system. (Led by the State Food and Drug Administration, with the cooperation of provincial people's governments in pilot areas)

(20) Optimize the import approval of drugs and medical devices. Simplify the review and approval of traditional oral proprietary Chinese medicines that have been listed in Hong Kong and Macao. We will optimize the management of imported medicinal materials and expand the import of high-quality medicinal materials from abroad. After obtaining China's drug approval documents, the commercial-scale batches of products that meet the requirements before approval are allowed to be imported and sold. We will optimize the review and approval process for transferring overseas pharmaceutical and medical devices that have been listed in China to domestic production, and support foreign-invested enterprises to introduce original drugs and high-end medical equipment to domestic production. (State Food and Drug Administration)

(21) Supporting the export trade of pharmaceuticals and medical devices. We will accelerate efforts to join the International Drug Inspection Cooperation Program. The scope of issuing export sales certificates will be extended to all drugs and medical devices produced by qualified enterprises in accordance with production quality management norms. Strengthen international exchanges and cooperation in TCM resources, actively carry out international regulatory policy publicity and exchanges, and support the registration and listing of TCM with clinical advantages overseas. (The Ministry of Commerce, the State Administration of Traditional Chinese Medicine and the State Food and Drug Administration shall be responsible according to the division of responsibilities)

Sixth, establish a regulatory system that meets the needs of industrial development and safety

22. Continue to strengthen regulatory capacity building. We will optimize the establishment of regulatory and technical support institutions, strengthen the construction of specialized teams, and enrich high-quality specialized technical forces. Gradually assign more responsibilities to the evaluation and inspection sub-centers that meet the standards, expand the scope of evaluation products and inspection enterprises, and steadily develop the evaluation and inspection capabilities that are compatible with the characteristics of regional industries. Promote the ability evaluation of medical device review institutions and reviewers in provincial drug regulatory departments. Encourage all localities to improve the local supervision system and mechanism in light of the actual development of the pharmaceutical industry, and strengthen the capacity building of the team. Encourage qualified provincial drug regulatory departments to actively promote the pilot reform and carry out more drug and medical device evaluation and other work. (The National Food and Drug Administration takes the lead, and the Ministry of Human Resources and Social Security and the provincial people's governments are responsible according to the division of responsibilities)

(23) Vigorously develop the science of drug regulation. With the national key laboratory for drug regulatory science as the leader, we will strengthen the construction of scientific innovation research bases for drug regulatory science. Deployment and promotion of drug regulatory science and technology research tasks, improve the transformation of results and incentive mechanisms for researchers, and accelerate the development of new tools, new standards, and new methods to support regulatory decision-making. (The Ministry of Science and Technology and the State Food and Drug Administration shall be responsible according to the division of responsibilities)

24. We will strengthen the application of information technology in supervision. Promote drug and medical device regulatory government services from application, acceptance, review to the full process of online processing. Improve the national drug smart supervision platform, strengthen the data collection and management of variety files and credit files, and explore the development of penetrative supervision. Promote the implementation and application of the unique identification of medical devices in promoting the coordinated development and governance of medical treatment, medical insurance and medicine. Strengthen the construction of the whole chain drug traceability system, implement the main responsibility of enterprises, and gradually realize the traceability of the whole process of production, circulation and use. (The National Food and Drug Administration takes the lead, and the National Development and Reform Commission, the Ministry of Industry and Information Technology, the National Health Commission and the National Medical Insurance Administration are responsible according to the division of responsibilities)

All regions and relevant departments should adhere to and strengthen the leadership of the Party throughout all aspects and the whole process of deepening the reform of pharmaceutical and medical device supervision, fully understand the importance of promoting the high-quality development of the pharmaceutical industry through reform, and do a good job in implementing these opinions in accordance with the "four strictest" requirements. Relevant departments should strengthen coordination, build synergy, strengthen funding and talent security, promote the implementation of various tasks, and ensure that various policies and measures are effective. Timely request instructions and report to the Party Central Committee and The State Council on major matters.