Guobanfa [2024] No. 53 Source: China Government Network Release Date: 2025-01-03

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

In order to thoroughly implement the important instructions and instructions 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 put forward.

I. General requirements

Guided by Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, we will fully implement the spirit of the 20th National Congress of the Communist Party of China and the Second and Third Plenary Sessions of the 20th Central Committee of the Communist Party of China, adhere to a scientific, law-based, internationalized, and modernized regulatory development path, coordinate high-quality development and high-level safety, deepen the reform of the entire process of drug and medical device supervision, accelerate the establishment of a unified national market in the field of drugs and medical devices, create an innovation ecosystem with global competitiveness, promote my country's transition from a major pharmaceutical country to a pharmaceutical power, and better meet the people's demand for high-quality drugs and medical devices.

By 2027, the regulatory laws and regulations for drugs and medical devices will be more complete, and the regulatory system, mechanism and 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, 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, the pharmaceutical industry will have stronger innovation and creativity and global competitiveness, and regulatory modernization will be basically achieved.

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

(I) Improve the review and approval mechanism to fully support major innovations. In accordance with the requirements of "early intervention, one policy for each enterprise, full guidance, and joint research and review", review and approval resources will be tilted more towards key innovative drugs and medical devices that are urgently needed in clinical practice, and communication and exchanges will be strengthened throughout the entire process of clinical trials, registration applications, verification and inspection, review and approval, and personalized guidance will be provided. (The State Drug Administration is responsible)

(II) Increase support for R&D and innovation of traditional Chinese medicine. Improve the evidence system for the review of traditional Chinese medicine that combines traditional Chinese medicine theory, human experience and clinical trials, and establish a mechanism for medical institutions to collect and organize human experience data in a standardized manner. Improve the regulatory system for traditional Chinese medicine that conforms to the characteristics of traditional Chinese medicine. Actively support the transformation of famous traditional Chinese medicine prescriptions and traditional Chinese medicine preparations in medical institutions into new traditional Chinese medicines. Encourage the use of new technologies, new processes and new dosage forms that conform to product characteristics to improve the varieties of traditional Chinese medicine that have been marketed. (The National Medical Products 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 duties)

(III) Give full play to the leading role of standards in the innovation of drugs and medical devices. Deepen the national action plan for improving drug and medical device standards, and actively promote the research and transformation of standards for new technologies, new methods, and new tools. Improve the national drug standard database, publish and timely update the online version of the Chinese Pharmacopoeia. Optimize the medical device standard system, study and establish cutting-edge medical device standardization technical organizations such as artificial intelligence and medical robots. Strengthen the formulation of traditional Chinese medical device standards. (The National Medical Products Administration takes the lead, and the Ministry of Industry and Information Technology, the National Health Commission, the State Administration of Market Regulation, and the State Administration of Traditional Chinese Medicine are responsible according to their respective duties)

(IV) Improve the relevant systems for the protection of intellectual property rights for drugs and medical devices. When some drugs are approved for marketing, a certain data protection period will be granted to the test data and other data submitted by the registration applicant that are obtained and not disclosed by themselves, according to their categories. A certain market exclusivity period will be granted to drugs for rare diseases, drugs for children, first chemical generic drugs and exclusive Chinese medicines that meet the conditions. Accelerate the patent layout of original achievements in drugs and medical devices, and improve the quality of patents and the benefits of transformation and application. (The National Intellectual Property Administration and the State Drug Administration are responsible for the division of responsibilities)

(V) Actively support the promotion and use of innovative drugs and medical devices. Increase the intensity of comprehensive clinical evaluation of innovative drugs, and strengthen the analysis and application of evaluation results. Study and pilot the self-evaluation of newly listed drug companies based on pharmaceutical and clinical value, and optimize the online listing service for newly listed drugs. Adhere to the "basic protection" functional positioning of basic medical insurance, improve the adjustment mechanism of the medical insurance drug catalog, study and standardize the medical insurance medical consumables catalog and medical service item catalog, 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. Improve the multi-level medical security system and enhance the diversified payment capacity 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)

III. Improving the quality and efficiency of drug and medical device review and approval

(VI) Strengthen pre-registration guidance for drugs and medical devices. Shorten the waiting time for communication and exchange on clinical trials of innovative drugs that are urgently needed. 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 for medical device innovation services, and strengthen the publicity and interpretation of registration and application rules. (National Medical Products Administration is responsible)

(VII) Accelerate the approval and marketing of urgently needed drugs and medical devices. Priority review and approval will be given to the application varieties of urgently needed cell and gene therapy drugs, overseas marketed drugs, combination vaccines, radioactive drugs, substitutes for rare and endangered medicinal materials, as well as high-end medical equipment and high-end implantable medical devices such as medical robots, brain-computer interface equipment, radioactive therapy equipment, medical imaging equipment, innovative traditional Chinese medicine diagnosis and treatment equipment. (The National Health Commission and the National Medical Products Administration are responsible according to their respective duties)

(VIII) Optimize the clinical trial review and approval mechanism. After the provincial drug regulatory authorities submit an application and the National Medical Products Administration agrees, a pilot program for optimizing the review and approval of clinical trials of innovative drugs will be carried out in some regions, shortening the review and approval period from 60 working days to 30 working days. The review and approval period for clinical trials of medical devices will be shortened from 60 working days to 30 working days. Optimize the bioequivalence test filing mechanism. (The National Medical Products Administration takes the lead, and the provincial people's governments in the pilot areas cooperate)

(IX) Optimize the review and approval of drug supplementary applications. After the provincial drug regulatory authorities submit an application and the State Drug Administration agrees, a pilot reform of the optimization of the review and approval procedures for drug supplementary applications will be carried out in some regions. The review period for supplementary applications that require verification and testing will be shortened from 200 working days to 60 working days. Optimize the management of raw materials, and the registration entity of raw materials can be changed according to law. (The State Drug Administration takes the lead, and the provincial people's governments in the pilot areas cooperate)

(10) Optimize the registration inspection of drugs and medical devices. Reduce the amount of each batch of drug registration inspection, biological product batch release inspection and imported drug customs clearance inspection from 3 times the amount of full inspection to 2 times. Open up a green channel for priority inspection of innovative drugs and medical devices, and implement immediate inspection for drugs and medical devices urgently needed in clinical practice. (National Medical Products Administration is responsible)

(XI) Accelerate the review and approval of drugs and medical devices for rare diseases. Reduce or exempt clinical trials for innovative drugs and medical devices for rare diseases that meet the requirements. Reduce the number of registration inspection batches for drugs for rare diseases from 3 batches to 1 batch, and reduce the dosage of each batch from 3 times the dosage of the full inspection to 2 times. Coordinate the registration verification and post-marketing inspection of imported drugs for rare diseases based on product risks, and shorten the waiting time for overseas inspections. Explore the possibility of specific medical institutions first importing drugs and medical devices for clinically urgently needed rare diseases that have not been registered and marketed domestically. Encourage national medical centers to increase the deployment and use of drugs and medical devices for rare diseases. Encourage high-level medical institutions to independently develop and use diagnostic reagents for rare diseases for which similar products are not yet available in China. (The National Health Commission and the National Medical Products Administration are responsible for their respective duties)

IV. Improving the compliance level of the pharmaceutical industry through efficient and strict supervision

(XII) Promote the authorization of batch release 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 batch release of biological products (vaccines). The batch release time limit for varieties such as seasonal influenza vaccines is shortened to within 45 working days. (Led by the National Medical Products Administration, with cooperation from provincial people's governments in relevant regions)

(XIII) Promote the improvement of generic drug quality. Optimize the review and verification mechanism of generic drugs, and increase the intensity of dynamic inspections before approval based on product risks. Strengthen the supervision of commissioned research and development, commissioned production and post-marketing changes, and support enterprises with high information technology levels, strong quality assurance and risk prevention and control capabilities to accept commissions. Gradually expand the evaluation of generic drug quality and efficacy consistency to eye drops, patches, sprays and other dosage forms. (National Drug Administration is responsible)

(XIV) Promote the informatization of production and inspection processes of pharmaceutical companies. Promote the deep integration of new-generation information technology and the pharmaceutical industry chain, and support the digital transformation of pharmaceutical and medical device manufacturers. Strictly supervise vaccine manufacturers to fully implement the requirements for informatization of production and inspection processes. Promote the informatization transformation of blood product production in batches, and promote the establishment of an informatization management system for blood products covering the entire process from plasma collection, factory entry 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 duties)

15. Improve the efficiency of drug and medical device supervision and inspection. Strengthen quality and safety warning education for enterprises, and urge enterprises to comprehensively improve their quality management systems. Reasonably determine the inspection frequency according to the risk level of enterprises and products, and reduce repeated inspections. Encourage national and provincial drug regulatory departments to jointly carry out registration site inspections and production quality management specification compliance inspections involving manufacturers. Carry out combined inspections for Class II and Class III medical device manufacturers that also produce Class I medical devices. (State Drug Administration is responsible)

(XVI) Strengthen vigilance for innovative drugs and medical devices. Guide and urge innovative drug marketing authorization holders to establish and improve drug vigilance systems, actively monitor, report and analyze adverse reactions, and continue to conduct post-marketing research on innovative drugs. Improve the drug adverse reaction and medical device adverse event monitoring platform based on the risk characteristics of innovative drugs and medical devices. Strengthen active post-marketing monitoring of innovative drugs and medical devices. (The National Health Commission and the National Medical Products Administration are responsible according to their respective duties)

(XVII) Improve the quality and effectiveness of supervision of new formats of pharmaceutical distribution. Establish a joint alliance for the safety risk management of online sales of drugs and medical devices, and strengthen the responsibility of third-party online trading platforms. 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 the retail chain rate. Chinese herbal medicine pieces prepared in accordance with provincial processing specifications can be sold across provinces as required, and Chinese herbal formula granules produced in accordance with national drug standards can be sold directly across provinces. (The National Medical Products Administration takes the lead, and the Ministry of Commerce, the National Health Commission, the State Administration of Market Regulation, and the State Administration of Traditional Chinese Medicine are responsible according to their respective duties)

V. Support the pharmaceutical industry to expand opening-up and cooperation

(XVIII) Deepen the transformation and implementation of international common regulatory rules. Continue to promote the coordination of drug review technical requirements with the rules of the International Council for Harmonization of Technical Regulations for Pharmaceuticals for Human Use, support drug clinical trial institutions to participate in the early clinical development of innovative drugs, support the conduct of international multi-center clinical trials, and promote the simultaneous development, simultaneous application, simultaneous review, and simultaneous listing of global drugs in my country. Actively promote the transformation and implementation of the technical guidelines of the International Forum of Medical Device Regulators and the Global Council for Harmonization of Medical Device Regulations in my country. (The National Health Commission and the National Medical Products Administration are responsible for the division of responsibilities)

(19) Explore the segmented production model of biological products. After the provincial drug regulatory department submits an application and the National Medical Products Administration agrees, a pilot project of segmented production of biological products with special requirements for production processes, facilities and equipment will be carried out in some regions, and the segmented production of antibody-drug conjugates, multi-component and multivalent vaccines will be promoted first. 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 National Medical Products Administration, with cooperation from provincial people's governments in pilot areas)

(XX) Optimize the 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 high-quality overseas medicinal materials. After obtaining the drug approval certificate of my country, overseas marketed drugs are allowed to be imported and sold for pre-approval commercial-scale batches that meet the requirements. Optimize the review and approval process for transferring overseas-produced drugs and medical devices that have been marketed in China to domestic production, and support foreign-invested enterprises to introduce original research drugs and high-end medical equipment into domestic production. (The State Food and Drug Administration is responsible)

(XXI) Support the export trade of medicines and medical devices. Accelerate the process of joining the international drug inspection cooperation program. Expand the scope of issuing export sales certificates to all qualified enterprises that produce medicines and medical devices in accordance with production quality management standards. Strengthen international exchanges and cooperation on Chinese medicine resources, actively carry out international regulatory policy publicity and exchanges, and support Chinese medicines with clinical advantages to be registered and marketed overseas. (The Ministry of Commerce, the State Administration of Traditional Chinese Medicine, and the State Drug Administration are responsible for their respective duties)

VI. Build a regulatory system that adapts to industrial development and safety needs

(XXII) Continue to strengthen regulatory capacity building. Optimize the setting of regulatory technical support institutions, strengthen the construction of professional teams, and enrich high-quality professional technical forces. Gradually give more responsibilities to review and inspection sub-centers that meet the capacity standards, expand the scope of review products and inspection enterprises, and steadily develop review and inspection capabilities that are compatible with regional industrial characteristics. Promote the capacity evaluation of medical device review institutions and reviewers in provincial drug regulatory departments. Encourage local governments to improve local regulatory systems and mechanisms and strengthen team capacity building in light of the actual development of the pharmaceutical industry. Encourage provincial drug regulatory departments with conditions to actively promote reform pilots and carry out more drug and medical device review and other work. (Led by the National Medical Products Administration, the Ministry of Human Resources and Social Security and provincial people's governments are responsible according to their respective responsibilities)

(XXIII) Vigorously develop drug regulatory science. With the National Key Laboratory of Drug Regulatory Science as the leader, strengthen the construction of drug regulatory science innovation research bases. Deploy and promote drug regulatory science and technology research tasks, improve the results transformation and scientific research personnel incentive mechanism, 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 National Medical Products Administration are responsible according to their respective responsibilities)

(XXIV) Strengthen the construction of regulatory informatization. Promote the online handling of all links and processes of government service matters for drug and medical device supervision, from application, acceptance, review to certification. Improve the national smart drug supervision platform, strengthen the data collection and management of product files and credit files, and explore the implementation of penetrating supervision. Promote the implementation and application of unique identification of medical devices in promoting the coordinated development and governance of medical care, medical insurance, and pharmaceuticals. Strengthen the construction of a full-chain drug traceability system, implement the main responsibilities of enterprises, and gradually realize the traceability of the entire process of production, circulation, and use. (The National Medical Products 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 their respective duties)

All regions and relevant departments should adhere to and strengthen the leadership of the Party throughout 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 coordination and cooperation, pool their efforts, strengthen funding and talent guarantees, promote the implementation of various tasks, and ensure that various policies and measures are implemented and effective. Important matters should be reported to the Party Central Committee and the State Council in a timely manner.

 General Office of the State Council

 December 30, 2024

source:National Drug Administration website

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