Guo Ban Fa [2024] No. 53

The people's governments of all provinces, autonomous regions, and municipalities directly under the Central Government; all ministries and commissions of the State Council and all institutions directly under the State Council,

In order to thoroughly implement the important instructions and directives of General Secretary Xi Jinping on the regulation of drugs and medical devices and the development of the pharmaceutical industry, and to comprehensively deepen reforms in drug and medical device regulation to promote the high-quality development of the pharmaceutical industry, the following opinions are proposed with the approval of the State Council.

I.  General Requirements

It is required to, taking Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era as the guide, fully implement the spirit of the 20th National Congress of the Communist Party of China (CPC) and the 2nd and 3rd Plenary Sessions of the 20th CPC Central Committee, adhere to the path of scientific, legal, international, and modern regulatory development, coordinate high-quality development and high-level safety, deepen the whole-process reform of drug and medical device regulation, accelerate the construction of a unified national market for drugs and medical devices, and foster a globally competitive innovation ecosystem to promote China's transformation from a major pharmaceutical manufacturer to a pharmaceutical powerhouse and better meet the people’s demand for high-quality drugs and medical devices.

By 2027, the legal and regulatory framework for drug and medical device regulation will be more robust, with a regulatory system, regulatory mechanisms, and regulatory approach that are better suited to the needs of pharmaceutical innovation and high-quality industrial development. The quality and efficiency of the review and approval process for innovative drugs and medical devices will be significantly improved. Whole-lifecycle regulation in this field will be strengthened to ensure product safety and quality. A regulatory system fit for pharmaceutical innovation and industrial development will be established. By 2035, China expects to fully ensure the quality, safety, efficacy, and accessibility of drugs and medical devices. The pharmaceutical industry will demonstrate stronger innovation, creativity, and global competitiveness, with its regulatory system modernized.

II. Increase support for innovation in R&D of drugs and medical devices

(I) Improve the review and approval mechanism to fully support major innovations. Following the principles of "early involvement, one enterprise one policy, whole process guidance, and research-review linkage", allocate more review and approval resources to clinically urgently needed key innovative drugs and medical devices. Strengthen communication and provide individualized guidance throughout the entire process of clinical trials, registration submission, inspection and testing, and review and approval. (National Medical Products Administration shall assume relevant responsibilities)

(II) Intensify support for innovation in R&D of traditional Chinese medicine. Refine the theory of traditional Chinese medicine-characteristic evidence-based review system that integrates human use experience and clinical trials. Establish a mechanism for standardized collection and organization of human use experience data by medical institutions. Establish a sound regulatory system for traditional Chinese medicine that conforms to the characteristics of traditional Chinese medicine. Actively support the transformation of prescriptions from renowned veteran traditional Chinese medicine practitioners and traditional Chinese medicine preparations from medical institutions into new traditional Chinese medicine. Encourage the application of new technologies, processes, and dosage forms that are in line with product characteristics to improve marketed traditional Chinese medicine varieties. (National Medical Products Administration shall take the lead; Ministry of Industry and Information Technology, National Health Commission, and National Administration of Traditional Chinese Medicine shall assume responsibilities according to respective duties)

(III) Give full play to the leading role of standards in the innovation of drugs and medical devices. Deepen the implementation of the national action plan for improving drug and medical device standards, and actively promote the research and transformation of standards for new technologies, methods, and tools. Refine the national drug standard database, and publish and timely update the online edition of the Chinese Pharmacopoeia. Optimize the medical device standard system, and research and establish standardization technology organizations for cutting-edge medical devices such as artificial intelligence and medical robots. Enhance the development of standards for traditional Chinese medical devices. (National Medical Products Administration shall take the lead; Ministry of Industry and Information Technology, National Health Commission, State Administration for Market Regulation, and National Administration of Traditional Chinese Medicine shall assume responsibilities according to respective duties)

(IV) Improve policies pertinent to intellectual property protection for drugs and medical devices. For certain drugs approved for marketing, grant categorized regulatory data protection at the time of marketing approval to clinical trial data and other data submitted by registration applicants that are independently obtained and undisclosed. Grant market exclusivity for drugs that meet specified conditions, including those for rare diseases, pediatric drugs, first chemical generic drugs, and exclusive traditional Chinese medicine. Accelerate patent planning for original achievements with regard to drugs and medical devices, and improve patent quality as well as translation and application benefits. (China National Intellectual Property Administration and National Medical Products Administration shall assume responsibilities according to respective duties)

(V) 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. Explore and pilot self-evaluation by MAHs for newly approved drugs based on CMC and clinical values, and optimize online publicity services for newly approved drugs. Adhere to the principle of "guaranteeing basic medical needs" in basic medical insurance, improve the adjustment mechanism for the medical insurance drug catalog, standardize the list of medical consumables and medical service items under medical insurance, and include eligible innovative drugs and medical devices in the medical insurance payment scope in accordance with procedures. Encourage clinical institutions to purchase and use these products. Improve the multi-level medical insurance system and enhance diversified payment capabilities for innovative drugs. Actively disseminate accurate and comprehensive information about innovative drugs and medical devices to the public. (Ministry of Industry and Information Technology, National Health Commission, State Administration for Market Regulation, National Healthcare Security Administration, and National Medical Products Administration shall assume responsibilities according to respective duties)

III. Improve review/approval quality and efficiency for drugs and medical devices

(VI) Enhance pre-registration guidance for drugs and medical devices. Shorten the communication timeline for clinical trials of clinically urgent innovative drugs. Carry out multi-channel and multi-level communication, effectively organize "cloud class on drug review" and "cloud class on device review", give full play to the roles of evaluation/inspection sub-centers and the central-local linkage mechanism for medical device innovation services, and enhance the publicity and interpretation of registration application rules. (National Medical Products Administration shall assume relevant responsibilities)

(VII) Accelerate the approval of clinically urgently needed drugs and medical devices. Grant priority review to clinically urgently needed cell and gene therapy, overseas marketed drugs, combination vaccines, radiopharmaceuticals, declared substitutes for rare and endangered medicinal materials, as well as high-end medical equipment such as medical robots, brain-computer interface devices, radiotherapy devices, medical imaging devices, innovative traditional Chinese medicine diagnostic and treatment devices, and high-end implantable medical devices. (National Health Commission and National Medical Products Administration shall assume responsibilities according to respective duties)

(VIII) Optimize the review and approval process for clinical trials. Provincial medical products administrations may submit pilot requests for NMPA approval. Once approved, the pilot programs will be conducted in partial regions to optimize clinical trial review and approval process for innovative drugs, shortening the review and approval timeline from 60 working days to 30 working days. Similarly, the clinical trial review and approval timeline for medical devices will also be shortened from 60 working days to 30 working days. Optimize the bioequivalence study filing process. (National Medical Products Administration shall take the lead; provincial people's governments in pilot regions shall provide cooperation)

(IX) Optimize the review and approval for drug supplemental applications. Provincial medical products administrations may submit pilot requests for NMPA approval. Once approved, the pilot programs will be conducted in partial regions to optimize the review and approval of drug supplemental applications, shortening the review and approval timeline from 200 working days to 60 working days for supplemental applications requiring inspection and testing. Optimize drug substance management by allowing changes to drug substance registration holders in accordance with the law. (National Medical Products Administration shall take the lead; provincial people's governments in pilot regions shall provide cooperation)

(X) Optimize registration testing for drugs and medical devices. Reduce the required sample quantity per batch from three times the full test amount to two times for registration testing, biologics batch release testing, and customs clearance testing of imported drugs. Establish a green channel for priority testing of innovative drugs and medical devices, and implement testing upon receipt for clinically urgently needed drugs and medical devices. (National Medical Products Administration shall assume relevant responsibilities)

(XI) Accelerate the review and approval of drugs and medical devices for rare diseases. Reduce or waive clinical trials for eligible innovative drugs and medical devices for rare diseases. For drugs for rare diseases, reduce the registration testing requirement from three batches to one batch, and reduce the required sample quantity per batch from three times the full test amount to two times. Coordinate registration inspections and post-marketing inspections for imported drugs for rare diseases based on product risks to shorten the waiting time for overseas inspections. Explore a pilot program allowing specified clinical institutions to import clinically urgently needed drugs and medical devices for rare diseases that have not been registered and marketed in China. Encourage national medical centers to enhance the allocation and utilization of drugs and medical devices for rare diseases. Encourage high-level clinical institutions to independently develop and use diagnostic reagents for rare diseases for which no product of the same kind has been marketed in China. (National Health Commission and National Medical Products Administration shall assume responsibilities according to respective duties)

IV.  Enhance the compliance of the pharmaceutical industry through efficient and strict regulation

(XII) Advance lot release authorization of biologics (including vaccines). On the basis of adequate risk assessment, gradually expand the scope of testing institutions under provincial drug regulatory authorities and the range of products authorized to implement lot release of biologics (including vaccines). Shorten the lot release timeline for products such as seasonal influenza vaccines to less than 45 working days. (National Medical Products Administration shall take the lead; provincial people's governments in relevant regions shall provide cooperation)

(XIII) Promote the quality improvement of generic drugs. Optimize the review and inspection mechanisms for generic drugs, and intensify pre-approval dynamic inspections based on product risks. Enhance the regulatory of outsourced research and development, contract manufacturing, and post-marketing changes, and provide support for enterprises with high levels of informatization, strong quality assurance, and robust risk prevention and control capabilities to act as contract acceptors. Gradually expand the scope of quality and efficacy consistency evaluations for generic drugs to include dosage forms such as eye drops, patches, sprays, etc. (National Medical Products Administration shall assume relevant responsibilities)

(XIV) Promote information-based manufacturing and testing in pharmaceutical enterprises. Promote the deep integration of new-generation information technologies with the pharmaceutical industry chain, and support the digital and intelligent transformation of drug and medical device manufacturers. Strictly supervise vaccine manufacturers to ensure the full implementation of the informatization requirements in manufacturing and testing processes. Promote the informatization transformation of blood product manufacturing in batches, and promote the establishment of an informatization management system for blood products covering the entire process from plasma collection and factory entry to manufacturing and testing. (Ministry of Industry and Information Technology, National Health Commission, and National Medical Products Administration shall assume responsibilities according to respective duties)

(XV) Enhance the efficiency of regulatory inspections for drugs and medical devices. Strengthen quality and safety warning education for enterprises, and urge them to comprehensively improve their quality management systems. Reasonably establish the inspection frequency based on risk levels of enterprises and products, and reduce repetitive inspections. Encourage national and provincial medical products administrations to jointly conduct registration on-site inspections and good manufacturing practice compliance inspections involving manufacturing enterprises. Conduct combined inspections for class II or III medical device manufacturers that also produce class I medical devices. (National Medical Products Administration shall assume relevant responsibilities)

(XVI) Strengthen pharmacovigilance for innovative drugs and medical devices. Guide and urge MAHs for innovative drugs to establish and refine pharmacovigilance systems, actively monitor, report, and analyze adverse reactions, and continuously conduct post-marketing studies for 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 post-marketing active monitoring of innovative drugs and medical devices. (National Health Commission and National Medical Products Administration shall assume responsibilities according to respective duties)

(XVII) Improve the regulatory quality and efficiency of new business forms in pharmaceutical circulation. Establish a joint governance alliance to address safety risks in the online sales of drugs and medical devices, and clarify the responsibilities of third-party online transaction platforms. Support wholesalers to effectively integrate warehousing and transportation resources, and build a multi-warehouse collaborative logistics management model. Optimize the licensing processes and increase the retail chain rate. Allow cross-provincial sales of traditional Chinese medicine decoction pieces processed according to provincial processing specifications, as well as direct cross-provincial sales of traditional Chinese medicine formula granules manufactured in accordance with national drug specifications. (National Medical Products Administration shall take the lead; Ministry of Commerce, National Health Commission, State Administration for Market Regulation, and National Administration of Traditional Chinese Medicine shall assume responsibilities according to respective duties)

V.  Support the pharmaceutical industry in expanding opening-up and international cooperation

(XVIII) Deepen the adoption and implementation of international general regulatory rules. Continue to promote the alignment of drug review technical requirements with the rules of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). Provide support for drug clinical trial institutions to participate in early clinical research and development of innovative drugs, and facilitate the conduct of international multi-center clinical trials. Promote the concurrent research and development, application, evaluation, and marketing of global drugs in China. Actively promote the adoption and implementation of technical guidelines from the International Medical Device Regulators Forum and the Global Harmonization Working Party towards Medical Device Harmonization in China. (National Health Commission and National Medical Products Administration shall assume responsibilities according to respective duties)

(XIX) Explore segmented production models for biologics. Provincial medical products administrations may submit pilot requests for National Medical Products Administration approval. Once approved, the pilot programs will be conducted in partial regions for biologics with special requirements for manufacturing processes, facilities, and equipment. Priority will be given to segmented production of antibody-drug conjugates, combined polyvalent vaccines, etc. Provide support for qualified overseas drug MAHs to carry out cross-border segmented production in the form of self-built manufacturing capacity or contract manufacturing under unified drug quality management systems. (National Medical Products Administration shall take the lead; provincial people's governments in pilot regions shall provide cooperation)

(XX) Optimize import approval of drugs and medical devices. Simplify the review and approval of traditional oral Chinese patent medicines that have been marketed in Hong Kong and Macao. Optimize the management of imported medicinal materials, and expand the import of overseas high-quality medicinal material resources. For overseas-marketed drugs that have obtained drug approval certificates in China, allow the import and sale of pre-approval commercial-scale batches that meet requirements. Optimize the review and approval process for localizing the manufacturing of overseas manufactured drugs and medical devices that have been marketed in China, and provide support for foreign-invested enterprises in localizing the manufacture of original drugs and high-end medical equipment. (National Medical Products Administration shall assume relevant responsibilities)

(XXI) Support the export trade of drugs and medical devices. Accelerate and promote inclusion into the international Pharmaceutical Inspection Co-operation Scheme. Expand the scope of export sales certificate issuance to include all drugs and medical devices manufactured by qualified manufacturers in accordance with good manufacturing practices. Strengthen international exchanges and cooperation with regard to traditional Chinese medicine resources, actively promote and exchange international regulatory policies, and support the overseas registration and marketing of traditional Chinese medicine with clinical superiorities. (Ministry of Commerce, National Administration of Traditional Chinese Medicine, and National Medical Products Administration shall assume responsibilities according to respective duties)

VI.  Build a regulatory system adapted to the needs of industrial development and safety

(XXII) Continuously strengthen the building of the regulatory capacity. Optimize the setup of regulatory technical support institutions, strengthen the development of professional teams, and enrich the pool of high-quality technical expertise. Gradually assign more responsibilities to evaluation/inspection sub-centers whose capabilities meet standards, expand the scope of evaluated products and inspected enterprises, and steadily develop evaluation and inspection capabilities tailored to regional industrial characteristics. Promote the capacity evaluation for medical device evaluation institutions and reviewers under provincial medical products administrations. Encourage each region to improve local regulatory systems and mechanisms and strengthen team capacity building in line with the actual development of the pharmaceutical industry. Encourage provincial drug regulatory authorities with the capacity to actively promote pilot reforms and increase the scope of drug and medical device evaluation work. (National Medical Products Administration shall take the lead; Ministry of Human Resources and Social Security and provincial people's governments shall assume responsibilities according to respective duties)

(XXIII) Vigorously developing drug regulatory sciences. With the national key laboratories for drug regulatory sciences as the leading force, strengthen the construction of innovation research bases for drug regulatory sciences. Deploy and advance key tasks in drug regulatory science and technology, improve mechanisms for the transformation of research outcomes, and enhance incentives for scientific research personnel. Accelerate the development of new tools, standards, and methods to support regulatory decision-making. (Ministry of Science and Technology and National Medical Products Administration shall assume responsibilities according to respective duties)

(XXIV) Strengthen regulatory informatization. Promote the online processing of drug and medical device regulatory government services, covering the entire process from application and acceptance to review and certificate issuance. Improve the national drug intelligence regulatory platform, strengthen the data collection and governance of product archives and credit records, and explore the implementation of comprehensive regulation. Promote the implementation and application of unique medical device identification in promoting the coordinated development and governance of healthcare services, health insurance, and the pharmaceutical industry. Strengthen the construction of a full-chain drug traceability system, enforce corporate accountability, and gradually achieve traceability throughout the process of manufacturing, distribution, and use. (National Medical Products Administration shall take the lead; National Development and Reform Commission, Ministry of Industry and Information Technology, National Health Commission, and National Healthcare Security Administration shall assume responsibilities according to respective duties)

All regions and relevant departments shall adhere to and strengthen the integration of the Party leadership into all aspects and throughout the entire process of deepening the reform of drug and medical device regulation, fully recognize the importance of advancing high-quality development of the pharmaceutical industry through these reforms, and implement the opinions herein in accordance with the "four strictest" requirements. Relevant departments shall strengthen collaboration and cooperation, consolidate efforts, enhance funding and talent support, promote the implementation and refinement of each task, and ensure the effective implementation of each policy and measure. In case of major issues, instructions shall be timely requested from the Party Central Committee and the State Council.

General Office of the State Council

December 30, 2024