To the people's governments of all provinces, autonomous regions, and municipalities directly under the Central Government, as well as all ministries and departments of the State Council and their directly affiliated institutions:
In order to thoroughly implement the important instructions and directives of General Secretary Xi Jinping on the supervision of drugs and medical devices and the development of the pharmaceutical industry, comprehensively deepen the reform of drug and medical device supervision, and promote the high-quality development of the pharmaceutical industry, with the approval of the State Council, the following opinions are proposed.
1、 Overall requirements
 
By 2027, the legal and regulatory system for the supervision of drugs and medical devices will be more perfect, and the regulatory system, mechanism, and methods will better adapt to the needs of pharmaceutical innovation and high-quality industrial development. The quality and efficiency of the review and approval of innovative drugs and medical devices will be significantly improved, and the supervision of the entire life cycle will be significantly strengthened. The quality and safety level will be comprehensively improved, and a regulatory system that is compatible with pharmaceutical innovation and industrial development will be established. By 2035, the quality, safety, effectiveness, and accessibility of drugs and medical devices will be fully guaranteed, and the pharmaceutical industry will have stronger innovation creativity and global competitiveness, basically achieving regulatory modernization.
2、 Intensify support for innovation in drug and medical device research and development
（1） Improve the review and approval mechanism to fully support major innovations. According to the requirements of "early intervention, one enterprise, one policy, full process guidance, and research review linkage", more resources for review and approval are tilted towards key innovative drugs and medical devices urgently needed in clinical practice. Communication and exchange are strengthened throughout the entire process of clinical trials, registration and application, verification and inspection, review and approval, and personalized guidance is provided. (Responsible for the National Medical Products Administration)
（2） Intensify support for research and innovation in traditional Chinese medicine. Improve the evidence system for evaluating the characteristics of traditional Chinese medicine by combining theory, human experience, and clinical trials, and establish a standardized mechanism for medical institutions to collect and organize human experience data. Establish a sound regulatory system for traditional Chinese medicine that conforms to its characteristics. Actively support the transformation of famous traditional Chinese medicine prescriptions and medical institutions' Chinese medicine preparations into new Chinese medicine drugs. Encourage the use of new technologies, processes, and dosage forms that are in line with product characteristics to improve existing varieties of traditional Chinese medicine on the market. (Led by the National Medical Products Administration, with the Ministry of Industry and Information Technology, the National Health Commission, and the State Administration of Traditional Chinese Medicine responsible for their respective duties)
（3） Give full play to the leading role of standards in the innovation of drugs and medical devices. We will deepen the action plan to improve national drug and medical device standards, actively promote the research and transformation of new technologies, methods, and tools. Improve the national drug standard database, publish and update the online version of the Chinese Pharmacopoeia in a timely manner. Optimize the medical device standard system, research and establish cutting-edge medical device standardization technology organizations such as artificial intelligence and medical robots. Strengthen the formulation of standards for traditional Chinese medicine medical devices. (Led by the National Medical Products Administration, the Ministry of Industry and Information Technology, the National Health Commission, the State Administration for Market Regulation, and the State Administration of Traditional Chinese Medicine are responsible for their respective roles and responsibilities.)
（4） Improve the relevant systems for intellectual property protection of drugs and medical devices. When some drugs are approved for market, a certain data protection period will be given to the self obtained and undisclosed trial data and other data submitted by the registration applicant according to their classification. Provide a certain market exclusivity period for rare disease drugs, pediatric drugs, the first chemical generic drugs, and exclusive traditional Chinese medicine varieties that meet the conditions. Accelerate the layout of original patents for drugs and medical devices, improve patent quality and conversion efficiency. (The China National Intellectual Property Administration and the State Food and Drug Administration shall be responsible according to the division of responsibilities)
（5） Actively support the promotion and use of innovative drugs and medical devices. Intensify the comprehensive clinical evaluation of innovative drugs and strengthen the analysis and application of evaluation results. Research and pilot the self-evaluation of newly listed drug companies based on pharmaceutical and clinical values, and optimize the online listing services for newly listed drugs. Adhere to the positioning of the "basic medical insurance" function, improve the adjustment mechanism of the medical insurance drug catalog, study and standardize the medical consumables catalog and medical service project catalog of the medical insurance, include eligible innovative drugs and medical devices in the scope of medical insurance payment according to procedures, and encourage medical institutions to purchase and use them. Improve the multi-level medical security system and enhance the diversified payment capability of 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 for Market Regulation, the National Medical Insurance Administration, and the National Medical Products Administration are responsible for their respective duties.)
3、 Improve the quality and efficiency of drug and medical device evaluation and approval
（6） Strengthen the pre registration guidance for drug and medical device applications. Shorten the waiting time for communication and exchange in clinical trials of urgently needed innovative drugs. Carry out multi-channel and multi-level communication, run the "Drug Review Cloud Classroom" and "Device Review Cloud Classroom" well, give full play to the role of the review and inspection sub center and the central local linkage mechanism of medical device innovation services, and strengthen the publicity and interpretation of registration and application rules. (Responsible for the National Medical Products Administration)
（7） Accelerate the approval and listing of urgently needed clinical drugs and medical devices. Priority review and approval will be given to the declared varieties of urgently needed cell and gene therapy drugs, overseas marketed drugs, combination vaccines, radioactive drugs, rare and endangered medicinal substitutes, as well as high-end medical equipment such as medical robots, brain computer interface devices, radiation therapy devices, medical imaging devices, innovative traditional Chinese medicine diagnostic and treatment devices, and high-end implantable medical devices. (The National Health Commission and the National Medical Products Administration are responsible for their respective roles and responsibilities.)
（8） Optimize the clinical trial review and approval mechanism. After the provincial drug regulatory department submitted an application and the National Medical Products Administration approved it, a pilot program for optimizing and innovating clinical trial review and approval of drugs will be launched in some areas, shortening the review and approval time from 60 working days to 30 working days. The time limit for clinical trial review and approval of medical devices has been shortened from 60 working days to 30 working days. Optimize the filing mechanism for bioequivalence testing. (Led by the National Medical Products Administration, with cooperation from provincial governments in pilot areas)
（9） Optimize the review and approval of drug supplement applications. After the provincial drug regulatory department submitted an application and the National Medical Products Administration approved it, a pilot reform of the review and approval procedures for optimizing drug supplementary applications will be carried out in some areas. The review time limit for supplementary applications that require verification and inspection will be shortened from 200 working days to 60 working days. Optimize the management of active pharmaceutical ingredients, and the registration subject of active pharmaceutical ingredients can be changed in accordance with the law. (Led by the National Medical Products Administration, with cooperation from provincial governments in pilot areas)
（10） Optimize the registration and inspection of drugs and medical devices. Reduce the usage of each batch for drug registration inspection, biological product batch issuance inspection, and imported drug clearance inspection from three times the total inspection usage to two times. Smooth the green channel for priority inspection of innovative drugs and medical devices, and implement immediate acceptance and inspection for clinically urgently needed drugs and medical devices. (Responsible for the National Medical Products Administration)
（11） Accelerate the review and approval of drugs and medical devices for rare diseases. Exemption from clinical trials for innovative drugs and medical devices that meet the criteria for rare diseases. Reduce the registration inspection batch of drugs for rare diseases from 3 batches to 1 batch, and reduce the dosage of each batch from 3 times the total inspection dosage to 2 times. Arrange registration verification and post market inspection of imported rare disease drugs based on product risk coordination, and shorten the waiting time for overseas verification. Explore the importation of clinically urgently needed rare disease drugs and medical devices by specific medical institutions that have not been registered and marketed domestically. Encourage national medical centers to increase the allocation and use of drugs and medical devices for rare diseases. Encourage high-level medical institutions to independently develop and use rare disease diagnostic reagents that have not yet been launched in China. (The National Health Commission and the National Medical Products Administration are responsible for their respective roles and responsibilities.)
4、 Enhancing the compliance level of the pharmaceutical industry through efficient and strict supervision
（12） Promote the authorization of batch issuance of biological products (vaccines). On the basis of fully assessing risks, gradually expand the scope of provincial-level drug regulatory inspection and testing institutions and varieties authorized to implement batch issuance of biological products (vaccines). The batch issuance deadline for seasonal influenza vaccines and other varieties has been shortened to within 45 working days. (Led by the National Medical Products Administration, with cooperation from relevant regional and provincial governments)
（13） Promote the improvement of generic drug quality. Optimize the review and verification mechanism for generic drugs, and increase the dynamic inspection intensity before approval based on product risks. Strengthen the supervision of commissioned research and development, commissioned production, and post listing changes, and support enterprises with high levels of information technology, strong quality assurance, and risk prevention capabilities to accept commissions. Gradually expand the evaluation of quality and efficacy consistency of generic drugs to eye drops, patches, sprays and other dosage forms. (Responsible for the National Medical Products Administration)
（14） Promote the informatization of production and inspection processes in pharmaceutical enterprises. Promote the deep integration of new generation information technology and the pharmaceutical industry chain, and support the digital transformation of pharmaceutical and medical device manufacturing enterprises. Strictly supervise vaccine production enterprises to fully implement the information technology requirements for production and inspection processes. Promote the informatization transformation of blood product production in batches, and establish an information management system for blood products that covers the entire process from plasma collection, entry into the factory to production and inspection. (The Ministry of Industry and Information Technology, the National Health Commission, and the National Medical Products Administration are responsible for their respective roles and responsibilities.)
（15） Improve the efficiency of drug and medical device supervision and inspection. Strengthen quality and safety warning education for enterprises, and urge them to comprehensively improve their quality management system. Reasonably determine the inspection frequency based on the risk level of the enterprise and product, and reduce duplicate inspections. Encourage national and provincial drug regulatory departments to collaborate in conducting on-site registration inspections and compliance checks with production quality management standards involving manufacturing enterprises. Conduct merger inspections on second and third class medical device manufacturing enterprises that simultaneously produce first class medical devices. (Responsible for the National Medical Products Administration)
（16） Strengthen the vigilance of innovative drugs and medical devices. Guide and urge holders of marketing licenses for innovative drugs to establish and improve drug surveillance systems, actively monitor, report, and analyze adverse reactions, and continue to conduct post marketing research on innovative drugs. Improve the monitoring platform for adverse drug reactions and medical device adverse events based on the risk characteristics of innovative drugs and medical devices. Strengthen proactive monitoring of innovative drugs and medical devices after they are launched. (The National Health Commission and the National Medical Products Administration are responsible for their respective roles and responsibilities.)
（17） Improve the quality and efficiency of supervision of new forms of pharmaceutical circulation. Establish a joint governance alliance for the security risks of online sales of drugs and medical devices, and strengthen the responsibility of third-party platforms for online transactions. Support wholesale enterprises to effectively integrate warehousing and transportation resources, and build a multi warehouse collaborative logistics management model. Optimize the licensing process and increase the retail chain rate. Traditional Chinese medicine decoction pieces processed according to provincial processing standards can be sold across provinces according to regulations, and traditional Chinese medicine formula granules produced according to national drug standards can be directly sold across provinces. (Led by the National Medical Products Administration, with the Ministry of Commerce, the National Health Commission, the State Administration for Market Regulation, and the State Administration of Traditional Chinese Medicine responsible for their respective duties)
5、 Supporting the pharmaceutical industry to expand its opening-up and cooperation with the outside world
（18） Deepen the transformation and implementation of international universal regulatory rules. Continuously promote the technical requirements for drug evaluation to be consistent with the rules of the International Conference on the Technical Coordination of Medicinal Products for Human Use, support drug clinical trial institutions to participate in early clinical research and development of innovative drugs, support the conduct of international multicenter clinical trials, and promote the synchronous research and development, application, evaluation, and market launch of global drugs in China. Actively promote the transformation and implementation of the International Medical Device Regulatory Forum and the Global Medical Device Regulatory Coordination Technical Guidelines in China. (The National Health Commission and the National Medical Products Administration are responsible for their respective roles and responsibilities.)
（19） Explore the segmented production mode of biological products. After the provincial drug regulatory department submitted an application and the National Medical Products Administration approved it, a pilot project for segmented production of biological products with special requirements for production processes and facilities and equipment will be launched in some areas, taking the lead in promoting segmented production of antibody conjugated drugs and multi valent vaccines. Support eligible overseas drug marketing authorization holders to carry out cross-border segmented production through self built production capacity or commissioned production under a unified drug quality management system. (Led by the National Medical Products Administration, with cooperation from provincial governments in pilot areas)
（20） Optimize the import approval of drugs and medical devices. Simplify the review and approval of listed traditional oral traditional Chinese patent medicines and simple preparations in Hong Kong and Macao. Optimize the management of imported medicinal materials and expand the import of high-quality medicinal materials resources from overseas. After obtaining the drug approval certificate from China, overseas marketed drugs are allowed to import and sell pre approved commercial batches of products that meet the requirements. Optimize the review and approval process for transferring overseas produced drugs and medical devices that have already been listed in China to domestic production, and support foreign-invested enterprises to introduce original research drugs and high-end medical equipment into domestic production. (Responsible for the National Medical Products Administration)
（21） Support the export trade of drugs and medical devices. Accelerate the accession to the International Drug Inspection Cooperation Program. Expand the scope of issuing export sales certificates to all qualified enterprises that produce drugs and medical devices in accordance with production quality management standards. Strengthen international exchange and cooperation of traditional Chinese medicine resources, actively promote and exchange international regulatory policies, and support the registration and listing of clinically advantageous traditional Chinese medicines overseas. (The Ministry of Commerce, the State Administration of Traditional Chinese Medicine, and the State Administration for Market Regulation are responsible for their respective duties.)
6、 Building a regulatory system that adapts to industrial development and safety needs
（22） Continuously strengthen the construction of regulatory capacity. Optimize the establishment of regulatory 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 with the ability to meet standards, expand the scope of evaluation products and inspection enterprises, and steadily develop evaluation and inspection capabilities that are suitable for regional industrial characteristics. Promote the evaluation of the capabilities of medical device review institutions and reviewers by provincial drug regulatory departments. Encourage various regions to combine the actual development of the pharmaceutical industry, improve local regulatory systems and mechanisms, and strengthen team capacity building. Encourage provincial drug regulatory departments with conditions to actively promote reform pilot projects and carry out more drug and medical device evaluation work. (Led by the National Medical Products Administration, with the Ministry of Human Resources and Social Security and provincial governments responsible according to their respective roles and responsibilities)
（23） Vigorously develop drug regulatory science. Taking the National Key Laboratory of Drug Regulation Science as the leader, we will strengthen the construction of drug regulation science innovation research bases. Deploy and promote scientific and technological research and development tasks for drug regulation, improve the mechanism for transferring achievements and incentivizing researchers, and accelerate the development of new tools, standards, and methods to support regulatory decision-making. (The Ministry of Science and Technology and the National Medical Products Administration are responsible for their respective roles and responsibilities.)
（24） Strengthen the construction of regulatory informatization. Promote the online processing of government services related to drug and medical device regulation, covering the entire process from application, acceptance, review to certification. Improve the national drug intelligent supervision platform, strengthen the data collection and governance of variety archives and credit archives, and explore the implementation of penetrating supervision. Promote the implementation and application of unique identification for medical devices in promoting the coordinated development and governance of healthcare, medical insurance, and pharmaceuticals. Strengthen the construction of a full chain drug traceability system, implement the main responsibility of enterprises, and gradually achieve traceability throughout the entire process of production, circulation, and use. (Led by the National Medical Products Administration, 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 for their respective duties.)
All regions and relevant departments should integrate and strengthen the leadership of the Party into all aspects and the entire process of deepening the reform of drug and medical device supervision, fully recognize the importance of promoting high-quality development of the pharmaceutical industry through reform, and implement this opinion in accordance with the "four strictest" requirements. Relevant departments should strengthen collaboration and cooperation, consolidate work force, enhance funding and talent guarantee, promote the implementation and refinement of various tasks, and ensure the effectiveness of various policy measures. Promptly request and report major issues to the Party Central Committee and the State Council.