Preface

Implement the scientific action plan of China's drug regulation. Keep up with the frontiers of world drug regulatory science, strengthen regulatory policy research, rely on universities and scientific research institutions to establish drug regulatory scientific research bases, and accelerate the research and application of new regulatory tools, new standards, and new methods.

Incorporate drug regulatory scientific research into relevant national science and technology plans, focusing on supporting regulatory scientific research in the fields of traditional Chinese medicine, biological products (vaccine), genetic medicine, cell medicine, artificial intelligence medical devices, new medical device materials, and new cosmetic raw materials, and speed up new products R&D and listing.

Implementation Opinions on Comprehensively Strengthening the Capacity Building of Drug Supervision
 
Source: General Office of the State Council

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 directly affiliated institutions:

Drug safety concerns the health and life safety of the people. Since the 18th National Congress of the Communist Party of China, the reform of drug supervision has been intensified, innovation, quality, and efficiency have been continuously improved, the pharmaceutical industry has developed rapidly and healthily, and the people's drug needs have been better met. As reforms continue to advance in depth, shortcomings in the drug regulatory system and regulatory capabilities have become increasingly prominent, affecting the people's sense of gain in drug regulatory reforms. In order to comprehensively strengthen the construction of drug regulatory capacity and better protect and promote the health of the people, with the consent of the State Council, the following opinions are hereby put forward.

total requirements

Guided by Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, fully implement the spirit of the 19th National Congress of the Communist Party of China and the 2nd, 3rd, 4th and 5th Plenary Sessions of the 19th National Congress of the Communist Party of China, and earnestly strengthen the "four consciousnesses" and strengthen the "four self-confidence." , Achieve the "two maintenances", earnestly implement the decisions and deployments of the Party Central Committee and the State Council, adhere to the people first and life first, implement the "four strictest" requirements, strengthen the foundation, make up for shortcomings, break bottlenecks, promote improvement, and benchmark international General rules, deepen the reform of the review and approval system, continue to promote regulatory innovation, strengthen the construction of the regulatory team, accelerate the establishment of a scientific, efficient and authoritative drug regulatory system in accordance with the requirements of high-quality development, resolutely maintain the bottom line of drug safety, and further improve drug regulatory work Scientification, legalization, internationalization, and modernization have promoted our country's leap from a major pharmaceutical country to a powerful pharmaceutical country, and better meets the people's needs for drug safety.

Key task
 
(1) Improve the legal system. Fully implement the "Drug Administration Law of the People's Republic of China", "Traditional Chinese Medicine Law of the People's Republic of China", "Vaccine Administration Law of the People's Republic of China", "Regulations on the Supervision and Administration of Medical Devices," "Regulations on the Supervision and Administration of Cosmetics", etc., and accelerate the formulation and revision of supporting facilities Regulations and regulations. Clean up and improve regulatory documents in a timely manner, advance the formulation and revision of technical guidelines in an orderly manner, and build a more systematic and complete system of laws and regulations for drug supervision.
 
(2) Improve standard management capabilities. Accelerate the improvement of relevant standard working mechanisms led by the government, the main body of enterprises, and the participation of the society. Continue to implement the national drug standard improvement action plan. Strengthen the construction of the drug standard system, improve the standard management system and measures, and strengthen the refined management of the entire process of standard formulation and revision. Improve the medical device standard system, build a cosmetics standard system, and strengthen the overall coordination of national standards, industry standards, group standards, and corporate standards. Actively participate in the coordination of relevant international standards and improve the degree of consistency with international standards. Strengthen the construction of standard information and improve the level of public standard services.

(3) Improve technical review capabilities. Aiming at the needs of national and regional coordinated development strategies, integrating existing regulatory resources, optimizing the establishment of review and inspection institutions such as traditional Chinese medicine and biological products (vaccine), and enriching professional technical strength. Optimize the joint work mechanism for research and review of emergency and innovative drugs and medical devices, and encourage the application of new technologies and the development of new products. Give full play to the role of the expert advisory committee in review and decision-making, and disclose expert opinions, review results and review reports in accordance with the law. Optimize communication methods and channels, increase the frequency of communication in innovative medicine and medical device conferences, and strengthen technical guidance and services to applicants. Improve the relevant systems for the import of overseas listed drugs that are urgently needed for clinical use. Establish a national drug toxicology collaborative research mechanism to strengthen the identification and control of hazardous substances in drugs.

(4) Optimize the review mechanism of traditional Chinese medicines. Follow the law of traditional Chinese medicine development, establish a characteristic review evidence system of traditional Chinese medicine that combines traditional Chinese medicine theory, human experience, and clinical trials, attach importance to the application of evidence-based medicine, and explore and carry out real-world evidence research on medicines. Optimize the registration classification of Chinese patent medicines, and strengthen the management of innovative medicines, improved new medicines, traditional Chinese medicine compound preparations with classic famous prescriptions, and medicines with the same name and the same prescription. Improve the technical guiding principle system, strengthen the quality control of the whole process, and promote the development of traditional Chinese medicine inheritance and innovation.

(5) Improve the inspection and law enforcement system. Implement the relevant deployment on the establishment of a professional and professional drug inspector team, and accelerate the construction of an inspector team system that effectively meets the needs of drug supervision at all levels. In response to the prominent problems exposed in the prevention and control of the new crown pneumonia epidemic and the investigation and handling of major cases, all provinces (autonomous regions and municipalities) should rely on existing resources to strengthen the construction of drug inspection institutions, enrich the team of inspectors, and extend their regulatory tentacles. Innovate inspection methods and strengthen the surprise and effectiveness of inspections. Strengthen overseas inspections to control the quality of imported drugs. Establish a unified dispatch mechanism for inspection forces. The National Drug Inspection Agency shall uniformly command and dispatch inspectors at all levels in accordance with the needs of major regulatory tasks. The provincial-level drug regulatory authorities shall coordinate and dispatch drug inspectors within their jurisdictions according to the needs of inspection and inspection work. Encourage city and county personnel engaged in drug inspection and testing to obtain the qualifications of drug inspectors and participate in drug inspections.

(6) Improve the investigation and case handling mechanism. Strengthen the construction of drug inspection teams, strengthen inspection and inspection coordination and law enforcement linkage, and improve the provincial-level market supervision and drug supervision working mechanism. To promote the implementation of the requirements for standardized construction of drug regulatory capabilities in cities and counties, the city and county-level market regulatory agencies should strengthen the deployment of drug regulatory law enforcement forces in the comprehensive law enforcement team to ensure that they have professional regulatory personnel, funds, and equipment that match the regulatory powers. Drug regulatory authorities at all levels and public security organs establish and improve the execution link mechanism, timely report major case information, transfer suspected drug crime cases, and severely crack down on illegal and criminal behaviors of drugs, especially vaccines.

(7) Strengthen the coordination of supervisory departments. Implement the division of regulatory powers, strengthen the coordination of cross-regional and cross-level drug supervision, and strengthen the supervision and coordination of drug supervision departments at the national, provincial, municipal, and county levels in the whole life cycle of drugs. Strengthen the supervision and guidance of provincial-level drug regulatory authorities on drug regulatory work of city and county-level market regulatory agencies, improve the linkage mechanism of information notification, joint case handling, and personnel deployment, and improve the drug safety risk consultation mechanism of provinces, cities, and counties to form drug supervision Work the pattern of a game of chess across the country.

(8) Improve inspection and testing capabilities. Aiming at the forefront of international technology, with the China Food and Drug Administration as the leader, the key laboratory of the State Food and Drug Administration as the backbone, and the provincial inspection and testing institutions as the support, we will improve the scientific and authoritative inspection and testing system for drugs, medical devices and cosmetics. Accelerate the construction of national key laboratories for the evaluation and verification of innovative vaccines and biotechnology products, and incorporate them into the national laboratory system. Continue to strengthen the construction of medical device inspection and testing institutions, accelerate the construction of inspection and testing and safety evaluation laboratories for banned and restricted substances in cosmetics, and make up for shortcomings in inspection and testing capabilities. Provincial-level inspection and testing agencies should strengthen the business guidance to the city and county-level inspection and testing agencies, and carry out capacity building up to standards.

(9) Enhance the ability of batch issuance of biological products (vaccine). Consolidate and improve the batch issuance capacity of biological products (vaccine) of the China Food and Drug Control Institute, promote the batch issuance capacity building of provincial drug inspection and testing institutions, and designate qualified provincial drug inspection and testing institutions as national biological products (vaccine) in accordance with laws and regulations. ) Batch issuing agency.

(10) Establish a national pharmacovigilance system. Strengthen the construction of the monitoring system for adverse reactions (events) of drugs, medical devices and cosmetics, and the capacity building of adverse drug reaction monitoring institutions at the provincial, city, and county levels. Formulate pharmacovigilance quality management standards, improve the information system, strengthen information sharing, and promote the application of data linkage with the disease control agency's suspected abnormal response monitoring system for vaccination.

(11) Improve cosmetic risk monitoring capabilities. Integrate risk information on cosmetics technical review and approval, supervision and sampling, on-site inspection, adverse reaction monitoring, complaints and reporting, public opinion monitoring, law enforcement inspections, etc., to build a unified and complete risk monitoring system, and form a coordinated and linked working mechanism. Promote the capacity building of high-throughput screening platforms, rapid inspection technology, and network monitoring of cosmetic safety risk substances, and gradually realize timely monitoring, accurate research and judgment, scientific early warning and effective disposal of cosmetic safety risks.

(12) Improve the emergency management system. Improve the emergency response plans for drug safety incidents of the people's governments at all levels, and improve the emergency management mechanism. Strengthen the unified command and coordination of inspection and testing, system verification, review and approval, and monitoring and evaluation in response to emergencies and major public health incidents. Strengthen the construction of the State Drug Administration's safety emergency drill center, carry out normalized drug safety emergency drills, and improve the emergency response capabilities of the drug regulatory agencies at all levels. Establish an emergency call mechanism for national reference material samples, effectively maintain emergency inspection equipment and facilities, and strengthen the research and development of key emergency technologies.

(13) Improve the information traceability system. Formulate unified drug information traceability standards, implement drug coding management, and implement the traceability responsibilities of drug marketing license holders. Build a national drug traceability collaboration platform to integrate traceability information in drug production, circulation, and use. Starting from vaccines, blood products, special drugs, etc., the sources of drugs and whereabouts can be traced gradually. Gradually implement the unique identification of medical devices and strengthen the connection with medical management and medical insurance management. Give full play to the role of traceability data in risk prevention and control, product recalls, emergency response, etc., and improve the level of delicacy of supervision.

(14) Promote digital management of the whole life cycle. Strengthen the application of big data in the supervision of drugs, medical devices and cosmetics, and improve the ability of data collection, correlation and financing, risk research and judgment, and information sharing from the laboratory to the end user throughout the life cycle. Strengthen the construction and application of drug, medical device and cosmetic product archives, strengthen the development and utilization of relevant data from government departments, industry organizations, enterprises, and third-party platforms, research and explore key common technologies and applications based on big data, and promote the digital upgrade of supervision and industry.

(15) Improve the application service level of "Internet + Drug Supervision". Promote the integrated application of the Industrial Internet in the regulatory fields of vaccines, blood products, and special drugs. Establish and improve the electronic general technical documentation system for drug registration and the electronic application information system for medical device registration, and promote the digitalization and networking of review and approval and license management. Accelerate the promotion of mobile internet applications in the cosmetics supervision field to improve work efficiency and service levels. Promote the interconnection, interoperability, sharing and sharing of the supervisory business systems at all levels and units, and gradually realize the "one network connection" and "cross-province operation". Adhere to the network management network, promote the construction of a network monitoring system, strengthen the supervision and inspection of online sales behavior, strengthen the management of online third-party platforms, and improve the quality supervision capabilities of online transactions of drugs, medical devices and cosmetics.

(16) Implementing the scientific action plan of China's drug regulation. Keep up with the frontiers of world drug regulatory science, strengthen regulatory policy research, rely on universities and scientific research institutions to establish drug regulatory scientific research bases, and accelerate the research and application of new regulatory tools, new standards, and new methods. Incorporate drug regulatory scientific research into relevant national science and technology plans, focusing on supporting regulatory scientific research in the fields of traditional Chinese medicine, biological products (vaccine), genetic medicine, cell medicine, artificial intelligence medical devices, new medical device materials, and new cosmetic raw materials, and speed up new products R&D and listing.

(17) Improve the quality of supervision team. Strengthen professional supervision requirements, strictly control the entry of supervision teams, and optimize the age and professional structure. Intensify training efforts, plan to focus on training high-level reviewers and inspectors, strengthen the training of high-level international talents, and achieve "double improvement" in the quantity and quality of core supervisory talents. All provinces (autonomous regions and municipalities) should improve the training program of provincial-level professional and specialized drug inspectors based on the actual situation of local pharmaceutical industry development and supervision tasks, and strengthen the training and practical training of drug regulatory personnel at the province, city, and county levels to continuously improve Case-handling capabilities, narrowing the gap in regulatory capabilities in different regions. Strengthen the construction of the national drug regulatory training base, and create an education and training system that integrates research, training, and drills. Make full use of information technology, build and promote the use of cloud platforms, and improve the accessibility and coverage of education and training.

(18) Improve the level of internationalization of supervision. To meet the needs of the globalization of drug supervision, participate in the international regulatory coordination mechanism, and actively participate in the formulation of international rules. Strengthen drug regulatory exchanges and cooperation with major trading countries and regions, and key countries and regions of the “Belt and Road” initiative. Use key products and key areas as breakthrough points to promote mutual recognition of supervision. Learn from international experience, improve the national drug regulatory quality management system, encourage local drug regulatory capabilities and levels to be upgraded, and promote the Beijing-Tianjin-Hebei, Guangdong-Hong Kong-Macao Greater Bay Area, the Yangtze River Delta and other regions to take the lead in achieving international advanced levels of drug regulatory capabilities.

Safety precautions

(19) Strengthen organization and leadership. All localities must conscientiously fulfill their political responsibilities for drug safety, especially vaccine safety, and insist that the party and the government share the same responsibilities, so that they are responsible for keeping the land and fulfilling their responsibilities. The people's governments at the provincial level should establish a drug safety coordination mechanism and strengthen the leadership of drug supervision. Local people's governments at all levels shall implement the responsibility for territorial management of drug safety, improve the responsibility system for drug safety, improve the assessment and evaluation system, and assume corresponding responsibilities for drug safety in their respective regions in accordance with the law.

(20) Improve the governance mechanism. Consolidate the main responsibility of drug safety companies and give full play to the self-discipline role of industry associations. Strengthen the coordination and linkage of relevant departments of drug management, strengthen the data connection application of drug supervision, medical management, and medical insurance management, realize the sharing of information resources, and form a joint force in drug safety governance. Implement credit supervision on drug safety, establish criteria for judging the list of serious violations of untrustworthiness, publicity systems, and information sharing mechanisms in accordance with laws and regulations, and implement joint credit punishments.

(21) Strengthen policy guarantees. Innovate and improve the funding guarantee policy that suits the characteristics of drug regulatory work, and rationally arrange regulatory funding. Establish a dynamic adjustment system for review and approval of corporate fees. Incorporate technical support services such as review, inspection, inspection, monitoring and evaluation, and standard management into the scope of government procurement services, optimize the structure of expenditures, and enhance the effectiveness of procurement services. Support local drug supervision work through special transfer payments.

(22) Optimize personnel management. Scientifically approve the number of personnel in technical institutions that perform the functions of review, inspection, inspection, monitoring and evaluation, and standard management. Establish the post of chief scientist and introduce senior professionals with international regulatory experience and familiar with the actual conditions of China's industry. Innovate and improve the human resources policy, strengthen policy support in terms of open recruitment, job setting, job title evaluation and employment, salary and package guarantee, and break the bottleneck of talent career development. Reasonably approve the total performance wages of relevant technical support institutions. In the distribution of performance wages, employees in high-risk supervisory positions such as on-site supervision can be inclined to better reflect the value of technical labor of the staff.

(Twenty-three) Incentive and responsible actions. Strengthen the ideological and political construction of the drug regulatory team, educate and guide cadres to effectively enhance the enthusiasm, initiative, and creativity of the officers and entrepreneurs, and faithfully perform the political responsibilities of drug regulatory.