The "14th Five-Year Plan" National Drug Safety and High-quality Development Plan

It was learned on December 30 that 8 departments including the State Food and Drug Administration jointly issued the "Fourteenth 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 promoting high-quality development, puts forward five "persistence" overall principles and main development goals, and formulates 10 main tasks to ensure drug safety during the "14th Five-Year Plan" period and promote high-quality drug development.
Promote the modernization of the drug regulatory system and regulatory capabilities to protect and promote public health
.

 

The Party Central Committee and the State Council attach great importance to drug supervision
.
General Secretary Xi Jinping issued 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 Long-term Goals for 2035" put forward strict drug supervision and made clear requirements on related work
.

 

The "Plan" thoroughly implements the idea of ​​socialism with Chinese characteristics in a new era of Jinping, implements the decisions and deployments of the Party Central Committee and the State Council, bases on the new development stage, implements the new development concept, builds a new development pattern, adheres to the people first, life first, and closely focuses on protecting drugs Safety, promote the high-quality development of drugs, promote the modernization of the drug regulatory system and regulatory capabilities, protect and promote the safety and health of the public's drug use, and propose major tasks and major projects
.
The "Plan" puts forward the need to grasp the overall principles of adherence to the overall leadership of the party, adherence to reform and innovation, adherence to scientific supervision, adherence to legal supervision, and adherence to social co-governance, and accelerate China’s leap from a pharmaceutical power to a pharmaceutical power.
So as to meet the health needs of the people
.

 

　　The "Plan" clarifies the main development goals during the "14th Five-Year Plan" period.
At the end of the "14th Five-Year Plan" period, the overall drug supervision and management capabilities are close to the international advanced level, the level of drug safety assurance continues to improve, and the people are more satisfied and more assured of drug quality and safety.

.
To support industrial development of high-quality regulatory environment is more optimized, review and approval system reform continued to deepen, the approval of a number of much-needed innovation in clinical medicine, accelerate the clinical value of new medicines on the market, in Chinese medicine to apply global innovation, innovative medical equipment in as soon as possible domestic market, the revision of Drug and medical Device cosmetics standard 2650 (a), the new guidelines 480; vaccine regulatory reached the international advanced level, through the World health Organization vaccine system to assess national regulators, and actively promote vaccine production enterprise provincial level where drugs test The institution has the ability to issue batches of major vaccines produced within its jurisdiction; new steps have been taken in the inheritance and innovative development of traditional Chinese medicine , and an evaluation evidence system combining traditional Chinese medicine theory, human experience and clinical trials has been initially established, and gradually explored the establishment of safety in line with the characteristics of traditional Chinese medicine The evaluation method and standard system, and the modern supervision system of traditional Chinese medicine are more complete; the construction of professional talent team has made great progress, and a group of high-level reviewers, inspectors and academic leaders with excellent professional quality in the field of inspection and testing have been cultivated with international advanced levels.
The professional quality of the drug regulatory team has improved significantly, and positive results have been achieved in the professionalization of the team; the technical support capabilities have been significantly enhanced, the full life cycle pharmacovigilance system has been initially established, the Chinese drug regulatory scientific 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 management system, continue to deepen the reform of the review and approval system, tighten vaccine supervision, and promote the inheritance and innovation of traditional Chinese medicine.
Strengthen the construction of technical support capacity, strengthen the construction of professional talents, strengthen the intelligent supervision system and capacity construction, strengthen the emergency system and capacity construction 10 main tasks
.

 

　　At the same time, the "Plan" puts forward the action plan for drug safety risk investigation, the national drug standard improvement action plan, the multi-sectoral collaborative policy toolbox for drug safety governance, speed up the construction of the review and approval system, improve the national adverse drug reaction monitoring system, and inspection and testing in the form of a column.
There are 10 key construction projects including the capacity improvement project, the promotion of the construction of the key laboratory of supervision science, the professional quality improvement project, the smart supervision project, and the emergency capacity improvement project
.

 

　　The "Plan" focuses on professional capacity building for review, inspection, inspection, monitoring and evaluation, and team building, and takes the drug regulatory system and regulatory capacity building as an important content
.
While "guaranteeing safety and keeping the bottom line", the "Plan" also proposes work measures to "promote development to catch up with the top line" and promote the high-quality development of drugs
.

 

　　The "Plan" requires that it be necessary to strengthen the overall coordination and leadership of drug safety work, innovate and improve support and guarantee mechanisms, actively participate in global drug safety governance, and encourage drug regulatory cadres to perform their duties and perform their duties
.
Local governments at all levels are responsible for drug safety in their respective regions, and provincial people's governments shall establish a drug safety coordination mechanism to coordinate drug safety and economic and social development
.

　　It was learned on December 30 that 8 departments including the State Food and Drug Administration jointly issued the "Fourteenth 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 promoting high-quality development, puts forward five "persistence" overall principles and main development goals, and formulates 10 main tasks to ensure drug safety during the "14th Five-Year Plan" period and promote high-quality drug development.
Promote the modernization of the drug regulatory system and regulatory capabilities to protect and promote public health
.

 

　　The Party Central Committee and the State Council attach great importance to drug supervision
.
General Secretary Xi Jinping issued 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 Long-term Goals for 2035" put forward strict drug supervision and made clear requirements on related work
.

 

　　The "Plan" thoroughly implements the idea of ​​socialism with Chinese characteristics in a new era of Jinping, implements the decisions and deployments of the Party Central Committee and the State Council, bases on the new development stage, implements the new development concept, builds a new development pattern, adheres to the people first, life first, and closely focuses on protecting drugs Safety, promote the high-quality development of drugs, promote the modernization of the drug regulatory system and regulatory capabilities, protect and promote the safety and health of the public's drug use, and propose major tasks and major projects
.
The "Plan" puts forward the need to grasp the overall principles of adherence to the overall leadership of the party, adherence to reform and innovation, adherence to scientific supervision, adherence to legal supervision, and adherence to social co-governance, and accelerate China’s leap from a pharmaceutical power to a pharmaceutical power.
So as to meet the health needs of the people
.

 

　　The "Plan" clarifies the main development goals during the "14th Five-Year Plan" period.
At the end of the "14th Five-Year Plan" period, the overall drug supervision and management capabilities are close to the international advanced level, the level of drug safety assurance continues to improve, and the people are more satisfied and more assured of drug quality and safety.

.
To support industrial development of high-quality regulatory environment is more optimized, review and approval system reform continued to deepen, the approval of a number of much-needed innovation in clinical medicine, accelerate the clinical value of new medicines on the market, in Chinese medicine to apply global innovation, innovative medical equipment in as soon as possible domestic market, the revision of Drug and medical Device cosmetics standard 2650 (a), the new guidelines 480; vaccine regulatory reached the international advanced level, through the World health Organization vaccine system to assess national regulators, and actively promote vaccine production enterprise provincial level where drugs test The institution has the ability to issue batches of major vaccines produced within its jurisdiction; new steps have been taken in the inheritance and innovative development of traditional Chinese medicine , and an evaluation evidence system combining traditional Chinese medicine theory, human experience and clinical trials has been initially established, and gradually explored the establishment of safety in line with the characteristics of traditional Chinese medicine The evaluation method and standard system, and the modern supervision system of traditional Chinese medicine are more complete; the construction of professional talent team has made great progress, and a group of high-level reviewers, inspectors and academic leaders with excellent professional quality in the field of inspection and testing have been cultivated with international advanced levels.
The professional quality of the drug regulatory team has improved significantly, and positive results have been achieved in the professionalization of the team; the technical support capabilities have been significantly enhanced, the full life cycle pharmacovigilance system has been initially established, the Chinese drug regulatory scientific 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 management system, continue to deepen the reform of the review and approval system, tighten vaccine supervision, and promote the inheritance and innovation of traditional Chinese medicine.
Strengthen the construction of technical support capacity, strengthen the construction of professional talents, strengthen the intelligent supervision system and capacity construction, strengthen the emergency system and capacity construction 10 main tasks
.

 

　　At the same time, the "Plan" puts forward the action plan for drug safety risk investigation, the national drug standard improvement action plan, the multi-sectoral collaborative policy toolbox for drug safety governance, speed up the construction of the review and approval system, improve the national adverse drug reaction monitoring system, and inspection and testing in the form of a column.
There are 10 key construction projects including the capacity improvement project, the promotion of the construction of the key laboratory of supervision science, the professional quality improvement project, the smart supervision project, and the emergency capacity improvement project
.

 

　　The "Plan" focuses on professional capacity building for review, inspection, inspection, monitoring and evaluation, and team building, and takes the drug regulatory system and regulatory capacity building as an important content
.
While "guaranteeing safety and keeping the bottom line", the "Plan" also proposes work measures to "promote development to catch up with the top line" and promote the high-quality development of drugs
.

 

　　The "Plan" requires that it be necessary to strengthen the overall coordination and leadership of drug safety work, innovate and improve support and guarantee mechanisms, actively participate in global drug safety governance, and encourage drug regulatory cadres to perform their duties and perform their duties
.
Local governments at all levels are responsible for drug safety in their respective regions, and provincial people's governments shall establish a drug safety coordination mechanism to coordinate drug safety and economic and social development
.