8 departments jointly issued the "14th Five-Year Plan" National Drug Safety and Promotion of High-quality Development Plan

It was learned on December 30 that a few days ago, the State Food and Drug Administration and other 8 departments jointly issued the "14th Five-Year Plan for National Drug Safety and Promotion of High-quality Development" (hereinafter referred to as the "Plan"), which clarified the period of China's "14th Five-Year Plan".
The guiding ideology of drug safety and the promotion of high-quality development, put forward five "adherence" overall principles and main development goals, and formulated 10 major tasks to ensure drug safety during the "14th Five-Year Plan" period and promote high-quality development of drugs, Advance the modernization of the drug regulatory system and regulatory capacity to protect and promote public health
.
The Party Central Committee and the State Council attach great importance to drug supervision
.
General Secretary Xi Jinping has made a series of important instructions and instructions on doing a good job in drug supervision
.
The Fourteenth Five-Year Plan for National Economic and Social Development of the People's Republic of China and the Outline of the Vision for 2035 put forward strict drug supervision and made clear requirements for related work
.
The "Plan" thoroughly implements Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, implements the decisions and arrangements of the CPC Central Committee and the State Council, bases itself on the new development stage, implements new development concepts, and builds a new development pattern.
Safety, promote the high-quality development of drugs, promote the modernization of the drug regulatory system and regulatory capacity, protect and promote the safety and health of public medication, and propose major tasks and major projects
.
The "Plan" proposes to grasp the overall principles of adhering to the overall leadership of the party, adhere to reform and innovation, adhere to scientific supervision, adhere to legal supervision, and adhere to social co-governance, and accelerate the promotion of China's leap from a big pharmaceutical country to a strong pharmaceutical country.
To meet the health needs of the people
.
The "Plan" clarifies the main development goals of the "14th Five-Year Plan" period.
At the end of the "14th Five-Year Plan" period, the overall drug supervision capability will approach the international advanced level, the level of drug safety assurance will continue to improve, and the people will be more satisfied and reassured about the quality and safety of drugs
.
The regulatory environment to support the high-quality development of the industry has been further optimized, the reform of the review and approval system has continued to deepen, a batch of innovative drugs urgently needed in clinical practice has been approved, and the launch of innovative drugs with clinical value has been accelerated.
Domestic listing, 2,650 (pieces) of pharmaceutical, medical, device and cosmetic standards have been formulated and revised, and 480 new guidelines have been added.
Vaccine supervision has reached the international advanced level.
It has passed the assessment of the World Health Organization vaccine national supervision system, and actively promoted the provincial-level drug inspection where vaccine manufacturers are located.
The institution has the ability to issue batches of the main varieties of vaccines produced within its jurisdiction; new steps have been taken in the inheritance, innovation and development of traditional Chinese medicine.
The evaluation method and standard system, the modern supervision system of traditional Chinese medicine are more perfect; the construction of professional talent team has made great progress, and a group of high-level reviewers and inspectors with international advanced level and professional quality leaders in the field of inspection and testing have been cultivated.
The professional quality of the drug regulatory team has been significantly improved, and positive results have been achieved in the professional construction of the team; the technical support capacity has been significantly enhanced, the full-life-cycle pharmacovigilance system has been initially established, the China Drug Regulatory Science Action Plan has achieved positive results, and the capabilities of drug inspection and testing institutions have been significantly improved
.
According to the development goals of the "14th Five-Year Plan", the "Plan" proposes to implement the whole-process supervision of drug safety, support industrial upgrading and development, improve the drug safety governance system, continue to deepen the reform of the review and approval system, strictly regulate vaccines, promote the inheritance, innovation and development of traditional Chinese medicine, There are 10 main tasks to strengthen technical support capacity building, strengthen professional talent team building, strengthen smart supervision system and capacity building, and strengthen emergency response system and capacity building
.
At the same time, the "Plan" proposes in the form of a column an ​​action plan for drug safety risk investigation, an action plan for improving national drug standards, a multi-department collaborative policy toolbox for drug safety governance, accelerating the construction of the review and approval system, improving the national adverse drug reaction monitoring system, inspection and testing There are 10 key construction projects including capacity improvement project, promotion of key laboratory construction of supervision science, professional quality improvement project, smart supervision project, and emergency response capacity improvement project
.
The "Plan" focuses on professional capacity building such as review, inspection, inspection, monitoring and evaluation, and team building, and takes the drug regulatory system and regulatory capacity building as an important content
.
While "safeguarding the bottom line", the "Plan" also proposes work measures to "promote development and follow the high line" and promote the high-quality development of pharmaceuticals
.
The "Plan" requires that it is necessary to strengthen the overall coordination and leadership of drug safety work, innovate and improve the support and guarantee mechanism, actively participate in global drug safety governance, and encourage the drug regulatory cadres to perform their duties and responsibilities
.
Local governments at all levels have overall responsibility for drug safety work in their respective regions, and provincial-level people's governments should establish a drug safety coordination mechanism to coordinate drug safety and economic and social development
.
Attachment: "14th Five-Year" National Plan for Drug Safety and Promotion of High-Quality Development