National Conference on drug registration management and post Market Supervision held in Beijing

From January 17 to 18, 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 China's characteristics, thoroughly implemented the decision and deployment of the Party Central Committee and the State Council on drug supervision, implemented the spirit of the National Conference on drug supervision and management, and summarized the registration and post marketing supervision in 2018, and deployed the work task for 2019 Li Li, Secretary of the Party group of the State Drug Administration, listened to the report of the meeting and put forward the requirements He stressed that the current situation and tasks of drug supervision should be studied in depth, and the key work in 2019 should be deployed and implemented Jiao Hong, director of the State Drug Administration, attended the meeting and made a speech Chen Shifei, deputy director of the State Drug Administration, presided over the meeting and made a summary Jiao Hong fully affirmed the achievements of drug supervision in 2018 In 2018, the reform of drug review and approval system continued to deepen, 48 new drugs such as treprilimumab injection were approved for listing, the consistency evaluation of quality and efficacy of generic drugs was steadily promoted, and the pilot of listing permit holder system achieved results; the intensity of on-site inspection continued to increase, the role of drug supervision sampling and risk monitoring was effectively played, and the level of drug safety risk prevention and control was further moved forward; it is appropriate to He is good at handling Changchun Changsheng vaccine cases, comprehensively screening risks of 45 vaccine manufacturers, and promoting the improvement of long-term mechanism of vaccine supervision; the State Food and drug administration has been successfully elected as a member of the Management Committee of the international human drug registration technology coordination committee (ICH), and the international discourse power of drug supervision has been continuously enhanced Jiao Hong stressed that in the next step, the drug regulatory authorities should seriously implement the "four strictest" requirements and strive to solve the problem of unbalanced and inadequate development of China's drug industry We will continue to promote the reform of "deregulation services", effectively supervise and optimize services through policy guidance, and promote the sustained and healthy development of the pharmaceutical industry We need to speed up the review and approval of drugs for urgent clinical needs and treatment of rare diseases, and formulate policies to encourage drug R & D and innovation We will promote the revision of laws and regulations, and constantly improve the construction of the standard system We will strengthen the supervision of key high-risk products, make good use of inspection, spot check, monitoring and other regulatory means, and strictly prevent, control and control safety risks Always adhere to the concept of scientific supervision, improve the supervision system and mechanism, strive to improve the scientific, legal, international and modern level of drug supervision, and continuously improve the people's satisfaction and sense of gain Chen Shifei pointed out in the summary of the conference that the reform of the organization alone established the State Drug Administration, highlighting the importance, particularity and professionalism of drug supervision Drug regulatory work should further strengthen the sense of mission and responsibility, focus on the central task of "adhere to one direction, firm two objectives, and consolidate three supports" put forward by the national drug regulatory work conference, and establish the governance concept of "big safety" and "big supervision" On the one hand, it should enhance the ability of scientific decision-making, risk prevention and control, and professional support, and strengthen the foundation On the other hand, under the unified leadership of the local Party committee and the government, we should eliminate the departmental system boundaries, fully mobilize the enthusiasm of all parties, and realize the social governance of drug safety The meeting made arrangements for the key work of drug registration management in 2019: improving drug registration laws and standards system, accelerating the formulation and revision of a series of rules and regulations such as measures for the administration of drug registration, continuing to promote the preparation of China Pharmacopoeia (version 2020); deepening the reform of drug review and approval system, improving the implied license of drug clinical trials, and further improving the drug clinical trial Bed test management ability and drug clinical research level; fully promote the consistency evaluation of generic drugs, adhere to the standard not to be lowered, further improve the relevant evaluation requirements and guiding principles, on the basis of ensuring the accessibility of drugs, promote by classification; strengthen the supervision of drug development, improve the on-site inspection management of drug registration, strengthen the organic connection between evaluation and inspection and inspection, and be strict Crack down on data fraud and ensure the authenticity of drug research At the same time, the meeting made clear the key tasks of post market drug supervision in 2019: to promote the formulation and revision of a series of supervision and management measures, such as drug production, circulation, spot check and inspection, adverse reaction monitoring, etc., in combination with the promulgation and implementation of the amendment to the drug management law; to clarify the supervision authority, refine the supervision process, highlight the supervision cooperation, and explore the establishment of the whole life cycle drug supervision mechanism; to strengthen We should strengthen the supervision of vaccines, promote the construction of professional drug inspectors, strengthen the management of vaccine batch issuance, strengthen the inspection of vaccine manufacturers, and supervise the illegal cases of vaccines by listing; strengthen the supervision of drug sampling and adverse reactions, strengthen the supervision of online drug sales, and strengthen the supervision of high-risk varieties; promote the construction of information traceability system, improve the efficiency of supervision; integrate the inspection and inspection We should work hard to establish a mechanism of coordination and linkage, make good use of the link between execution and punishment, and severely punish and punish illegal acts The meeting also stressed that in the drug registration management and post market supervision, we must constantly pay attention to the party's style of work and integrity, and build a drug supervision team with excellent business, solid style and integrity.