The General Office of the State Council issued the "Implementation Opinions on Comprehensively Strengthening the Capacity Building of Drug Supervision"
The General Office of the State Council recently issued the "Implementation Opinions on Comprehensively Strengthening the Capacity Building of Drug Supervision" (hereinafter referred to as the "Implementation Opinions").
The "Implementation Opinions" pointed out that drug safety is related to the health and life safety of the people.
Guided by Xi Jinping’s Thought on Socialism with Chinese Characteristics for a New Era, we must 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. "Requirements, deepen the reform of the review and approval system, continue to promote regulatory innovation, strengthen the construction of regulatory teams, accelerate the establishment of a scientific, efficient, and authoritative drug regulatory system, resolutely maintain the bottom line of drug safety, and further enhance the scientific, legal, and legal aspects of drug regulatory work. The level of internationalization and modernization has promoted China's leap from a big pharmaceutical country to a strong pharmaceutical country, and better meets the people's needs for drug safety.
The "Implementation Opinions" clarified 18 key tasks in six areas.
One is to improve the construction of laws and regulations and standard systems.
Speed up the formulation and revision of supporting laws and regulations, timely clean up and improve the normative documents, and advance the formulation and revision of technical guidelines in an orderly manner.
Accelerate the improvement of the standard work mechanism led by the government, the main body of the enterprise, and the participation of the society.
Strengthen the construction of standard information and improve the level of public standard services.
The second is to improve review capabilities and optimize review mechanisms.
Optimize the establishment of review and inspection institutions for traditional Chinese medicines and biological products (vaccine), optimize the working mechanism for joint research and review of emergency and innovative drugs and medical devices, and encourage the application of new technologies and the development of new products.
Optimize the evaluation mechanism of traditional Chinese medicine, follow the law of traditional Chinese medicine development, establish a characteristic evaluation evidence system of traditional Chinese medicine that combines traditional Chinese medicine theory, human experience, and clinical trials, and promote the inheritance and innovation of traditional Chinese medicine.
The third is to improve the inspection and law enforcement system and case-handling mechanism, and strengthen departmental coordination.
Speed up the establishment of an inspector team system that effectively meets the needs of drug supervision at all levels, and establish a unified dispatch mechanism for inspection forces.
Encourage personnel engaged in drug inspection and testing in cities and counties to obtain the qualifications of drug inspectors.
Improve the provincial-level market supervision and drug supervision work mechanism, and promote the implementation of the standardization construction requirements of the city and county drug supervision capabilities.
Drug regulatory departments at all levels and public security organs establish and improve the connection mechanism for execution of sentences.
Strengthen the coordination of drug supervision departments at the national, provincial, municipal and county levels in the supervision of the whole life cycle of drugs, and form a national chess pattern of drug supervision.
The fourth is to improve inspection and testing capabilities and improve the emergency management system.
Improve the scientific and authoritative inspection and testing system for drugs, medical devices and cosmetics, promote the batch issuance capacity building of provincial-level drug inspection and testing institutions, and strengthen the development of the adverse reaction (event) monitoring system and the capacity building of adverse reaction monitoring institutions at all levels.
The "Implementation Opinions" emphasized the need to 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 safety emergency drill center of the State Drug Administration.
Strengthen the research and development of key emergency technologies.
Fifth, improve the informatization traceability system and improve the application service level of "Internet + drug supervision".
Build a national drug traceability collaboration platform to realize drug traceability throughout the life cycle, and gradually implement unique identification of medical devices.
Strengthen the application of big data in the supervision of drugs, medical devices and cosmetics, and promote the digital upgrade of supervision and industry.
Promote the integrated application of the Industrial Internet in the regulatory fields of vaccines, blood products, and special drugs, promote the digitalization and networking of review and approval and license management, and promote the construction of a network monitoring system.
Sixth, implement China's Pharmaceutical Regulatory Scientific Action Plan to improve the quality of the regulatory team and the level of internationalization of supervision.
Establish a scientific research base for drug supervision and accelerate the research and application of new supervision tools, new standards, and new methods.
Strengthen professional supervision requirements, and strengthen training and practical training for supervisors.
Participate deeply in the international regulatory coordination mechanism, promote the realization of regulatory mutual recognition, and promote the regional regulatory capabilities of Beijing-Tianjin-Hebei, Guangdong-Hong Kong-Macao Greater Bay Area, and the Yangtze River Delta to take the lead in reaching the international advanced level.
The "Implementation Opinions" emphasized that it is necessary to strengthen organizational leadership, improve governance mechanisms, strengthen policy guarantees, optimize personnel management, and encourage responsible actions, comprehensively strengthen the construction of drug regulatory capabilities, and better protect and promote the health of the people.