On January 25, the National Drug Registration Management and Drug Post-marketing Supervision Work Conference was held in Beijing. Guided by Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, the meeting fully implemented the spirit of the 19th National Congress of the Communist Party of China and previous plenary sessions, implemented the spirit of the Central Economic Work Conference and the Sixth Plenary Session of the 19th Central Commission for Discipline Inspection, in accordance with the national drug supervision and management and party style. The deployment of the clean government construction work conference, summarizing the work in 2021, analyzing the current situation and tasks, and studying and deploying key tasks in 2022. Chen Shifei, member of the party group and deputy director of the State Food and Drug Administration, attended and delivered a speech. Zhao Junning, member of the party group and deputy director, and Li Bo, director of drug safety, attended the meeting.
The meeting fully affirmed the achievements of drug registration management and drug post-marketing supervision in 2021. Over the past year, the cadres and workers of the whole system have adhered to the guidance of Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, resolutely implemented the decisions and arrangements of the Party Central Committee and the State Council, and made every effort to prevent and control the new crown epidemic. New breakthroughs have been made in the reform of drug review and approval. New progress has been made in supervision and a good start to the “14th Five-Year Plan” has been achieved.
Chen Shifei pointed out that while fully summarizing the work achievements, we must also deeply understand the new situation and new tasks facing the current drug supervision work. The whole system must seek long-term strategies, implement solid foundations, do more research and solve deep-seated problems that affect drug quality and industrial development, and speed up to make up for shortcomings and weaknesses, so as to achieve high-quality development of drug supervision and accelerate the promotion of the development of the pharmaceutical industry from a big country. The leap to a pharmaceutical powerhouse.
Chen Shifei said that the general idea of drug supervision in 2022 is: adhere to the guidance of Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, thoroughly study and implement the spirit of the 19th National Congress of the Communist Party of China and previous plenary sessions, thoroughly implement the “four strictest” requirements, and adhere to the People-centered, accurately grasp the two major domestic and international situations, focus on key tasks, focus on the two major issues of security and development, seek progress while maintaining stability, better protect and promote the health of the people, and welcome the party’s 20th anniversary with outstanding achievements. Great victory held. The overall requirements are: to ensure the overall situation of anti-epidemic, resolutely win the battle of epidemic prevention and control, do a good job in the review and approval of vaccines and drugs, and ensure quality and supply; strictly adhere to the bottom line of safety, ensure that drug safety is foolproof, and carry out in-depth drug safety special rectification actions, Comprehensively strengthen the supervision of the entire life cycle of drugs; make up for shortcomings in capacity, improve the level of modernization of drug supervision, and match supervision capabilities with supervision tasks and industrial development; pursue high-level development, promote high-quality development of the drug industry, and provide people with health benefits More new medicines and good medicines.
The meeting made arrangements for the key work of drug registration management in 2022. It is necessary to go all out to do a good job of emergency review and approval, further improve the drug registration regulatory system, strengthen the construction of drug registration supervision capacity, do a good job in the review and supervision of post-market filing changes, and accelerate the construction of a complete review and approval system that conforms to the characteristics of traditional Chinese medicine. , strengthen the supervision of drug research institutions, continue to promote a series of special work such as the consistency evaluation of generic drugs, the re-evaluation of the national drug regulatory system for vaccines, and the encouragement of children’s drugs and rare disease drug research and development.
The meeting clarified the key work of post-marketing supervision of drugs in 2022. It is necessary to improve the political position, concentrate efforts, and continue to serve and ensure the overall situation of epidemic prevention and control; establish a bottom-line thinking, have a targeted, and do a good job in the supervision of key varieties; implement scientific and precise policies, make steady progress, and coordinate the work of post-marketing supervision of drugs; Focus on key issues, highlight key points, and continue to carry out special inspections; strengthen coordination and linkage, consolidate foundations, and strengthen drug regulatory capacity building.
At the meeting, the provincial drug administrations in Beijing, Hebei, Jiangsu, Zhejiang, Shandong, Hunan, Chongqing and other provinces exchanged work experience respectively.
The meeting is held in the form of a video conference. The relevant responsible comrades and relevant personnel of the Health Bureau of the Logistics Support Department of the Central Military Commission, the relevant departments and bureaus of the State Food and Drug Administration and directly affiliated units, the provinces (autonomous regions and municipalities), the Food and Drug Administration of the Xinjiang Production and Construction Corps, the market supervision departments of the provincial capital cities and cities under separate state planning, respectively Attend meetings at the main venue and branch venues.