2020 working conference on drug registration management and post marketing Supervision held in Beijing

From January 18 to 19, the National Conference on drug registration management and post marketing supervision was held in Beijing The meeting, guided by Xi Jinping's new socialist ideology with Chinese characteristics, fully implemented the spirit of the nineteen and nineteen sessions of the second, third and fourth plenary sessions of the party, and summarized the drug registration and post marketing supervision work in 2019 according to the China National Drug Supervision and management work conference It also sought to identify risks, analyze the situation and deploy various tasks in 2020 Chen Shifei, member of the Party group and deputy director of the State Drug Administration, attended the meeting and delivered a speech The meeting fully affirmed the achievements of drug registration management and post marketing supervision in 2019 Over the past year, the national drug regulatory system has adhered to the people-centered development concept, continued to deepen the reform of the review and approval system, continued to strengthen post IPO supervision, practically improved the system of laws and technical standards, continued to improve the ability of drug safety risk prevention and control, continued to optimize the development environment of the pharmaceutical industry, and achieved a good start in drug regulatory work under the new system: vaccine management law , the newly revised Drug Administration Law (hereinafter referred to as the "two laws") solidified the experience and achievements of the reform of drug review and approval system from the legal level, accelerated the formulation and revision of regulations, standards and technical guidelines based on the "two laws", and basically formed a drug life cycle supervision system with clear responsibilities, clear processes and standardized operation; We will continue to deepen the "release management service", optimize the drug review and approval process, speed up the listing of a number of new and good drugs urgently needed in clinical practice and eagerly awaited by the public, steadily improve the quality level of domestic generic drugs, and promote the inheritance and development of traditional Chinese Medicine and ethnic medicine; Focus on the difficult areas and outstanding problems of drug safety, carry out in-depth special rectification of Chinese herbal pieces, licensed pharmacists "hang license", strengthen the supervision of blood products, special drugs and other key products, effectively strengthen sampling monitoring; reconstruct the vaccine supervision system, strictly control vaccine risk, strengthen the vaccine supply guarantee system, and do a good job in vaccine NRA evaluation; We will strengthen leadership in Party building and professional team building, and achieve results in smart supervision Chen Shifei pointed out that in 2020, standing on the new journey of modernization of drug safety management system and management ability, we should be aware of the new requirements, new situation and new tasks of drug registration management and post marketing supervision, so as to "know the overall situation" and "make the general situation clear" "Seeking important matters" should be guided by scientific theories, solved with the people-centered position, strictly supervised with the concept of rule of law, bravely shouldered by professional teams, and resolutely put the "four strictest" into practice For the next work, Chen Shifei put forward four requirements: first, we should promote and implement laws and regulations, accelerate the formulation and revision of supporting rules and regulations, do a good job in the implementation of the new law, carry out extensive publicity and interpretation, and ensure the implementation and effectiveness of the new law Second, we should focus on risk prevention and control, continue to maintain the trend of strict vaccine management, focus on difficulties and carry out special governance, further strengthen post market supervision, and ensure the stability of security situation Third, we should deepen the reform, further optimize the registration management system, support and encourage R & D innovation, promote the level of generic drugs, and promote the reform of traditional Chinese medicine review and approval Fourth, we should focus on innovation in governance, promote the construction of professional inspectors, promote innovation in supervision technology and supervision methods, pool system efforts, and continue to modernize the capacity of the supervision system The meeting made plans for the key work of drug registration management in 2020: first, focus on the overall situation, coordinate the national drug registration management work, according to the local regulatory authority required by laws and regulations, refine and implement the work tasks at all levels of drug registration management, and play a good role in the whole life cycle management of drugs Second, we should pay attention to actual results, comprehensively promote the formulation and revision of supporting documents for the newly revised Measures for the administration of drug registration, and do a good job in the transition between the new and old regulations The third is to keep the positive innovation, reform and improve the registration management of traditional Chinese medicine, accelerate the establishment and improvement of traditional Chinese medicine safety and efficacy evaluation methods and technical standards in line with the characteristics of traditional Chinese medicine, and promote the inheritance and innovative development of traditional Chinese medicine Fourth, we should make overall planning, continue to do a good job in the listing of new drugs and good drugs, and promote the consistency evaluation of generic drugs The meeting also requested that the collection of prescription process information should be started as soon as possible, the supervision of drug development should be strengthened continuously, and the drug registration management work of each provincial drug regulatory department in 2020 should be guided At the same time, the meeting made clear the key tasks of post market drug supervision in 2020: first, based on the implementation of the "two laws", consolidate the basis of laws and regulations, strive to improve the mechanism and norms of post market drug supervision, and improve the level of legalization, scientificization and standardization of supervision Second, we should strengthen the supervision of high-risk products We should take the supervision of high-risk products, especially vaccines and blood products, as the top priority of post marketing supervision We should strengthen the supervision of the source of production links, strengthen the investigation of risk risks in all links, and find and resolve major risks in a timely manner Third, we should strengthen the implementation of corporate responsibility, adhere to problem orientation, risk prevention and control, continuously strengthen supervision and inspection, improve the efficiency of sampling inspection, and accelerate the promotion of drug vigilance system Fourth, in view of the links or areas where problem risks are prone to occur frequently, we will focus on special rectification, troubleshooting and resolving potential risks, so as to move forward Fifthly, around the continuous improvement of the regulatory capacity after drug listing, we should actively promote smart regulatory and regulatory science, and strengthen policy research, departmental coordination and emergency response In particular, the meeting stressed that drug supervision integrates examination and approval, supervision and law enforcement, reviews and approves a wide range of items, and supervises and enforces a wide range of points It is necessary to unswervingly promote the construction of a clean and honest government, realize the integration of supervision ability improvement and risk prevention of a clean and honest government, and strive to achieve the goal of high quality, high efficiency and integrity Representatives of the pharmaceutical supervision departments of all provinces (districts, cities) and Xinjiang production and Construction Corps, departments and bureaus of the State Administration of pharmaceutical supervision and the units directly under it attended the meeting.