[Industry Information] Concerns | Notice of the State Food and Drug Administrati

Copyfrom： Release time：2019-10-16 The editor：

[Industry Information] Concerns | Notice of the State Food and Drug Administration on Learning and Propagating the Drug Administration Law of the People's Republic of China
 


      The Drug Administration of provinces, autonomous regions and municipalities directly under the Central Government, the drug administration of Xinjiang Production and Construction Corps, the departments and bureaux of the Bureau organs and the units directly under them:
 
      The Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administration Law) was deliberated and adopted by the 12th meeting of the Standing Committee of the 13th National People's Congress on August 26, 2019, and has been in force since December 1, 2019. In order to do a good job in the publicity and implementation of the Drug Administration Law, we hereby inform you of the following matters:

 1、Deeply understand the legislative purpose and spirit, fully understand the importance of publicizing and implementing the Drug Administration Law

       Drug safety concerns the vital interests of the broad masses of the people and the overall situation of economic and social development. The CPC Central Committee and the State Council attach great importance to drug safety. General Secretary Xi Jinping and Premier Li Keqiang have issued important instructions and instructions on many occasions, calling for speeding up the improvement of the long-term mechanism of vaccine and drug supervision, as well as the improvement of laws, regulations and institutional rules. The revision of the Drug Administration Law will fully implement the central decision-making and deployment and the "four most stringent" requirements, promote reform by legislation, guarantee people's livelihood by law, strengthen drug management, ensure drug quality, guarantee the safety and legitimate rights and interests of the public in drug use, protect and promote public health as legislative purposes, and will play an extremely important role in protecting the rights and interests of the public in drug use and encouraging the innovation and development of the industry. It plays an important role.
 
       Guided by the spirit of the Nineteenth National Congress of the CPC and the Second and Third Plenary Sessions of the Nineteenth Central Committee, all regions and units should adhere to the people-centered approach as their starting point and foothold, fully implement the spirit of the important instructions and instructions of the CPC Central Committee and the State Council on drug safety supervision, and fully understand the propaganda and implementation of the Pharmaceutical Administration Law from the perspective of resolutely safeguarding the vital interests of the broad masses. Importance and necessity, strengthen sense of responsibility and mission, strengthen organizational leadership, clarify work tasks, implement work responsibilities, strengthen financial security, strictly supervise and assess, and actively carry out the study, publicity and implementation of the Drug Administration Law.


2、Grasp the Basic Principles and Key Contents to Ensure the Effective Implementation of New Systems
 
      The Drug Administration Law clearly states that drug management should be centered on people's health, adhere to the principles of risk management, whole process control and social co-governance, and make many major institutional innovations, such as drug license holders, drug traceability, drug vigilance, unified publication of drug safety information, punishment to people, around the requirements of encouraging innovation and life cycle management, to develop, register and punish drugs. The production, operation, use, post-marketing management, drug prices and advertisements, reserve and supply, supervision and management, and legal liability are all stipulated. Strengthen dynamic supervision, cancel GMP certification and GSP certification. Drug supervision and management department will check the implementation of GMP and GSP at any time. We should improve the responsibility system for drug safety, strengthen supervision after the event, lay stress on the regulation of disorder and severely punish illegal acts.
 
    All regions and units should take the study of the Drug Administration Law as an important task of current drug supervision, closely link with reality, deeply understand the basic principles of the Drug Administration Law, actively study and publicize the main responsibility of enterprises, the whole process management of drugs, drug safety supervision and inspection, investigation and punishment of illegal acts, and the implementation of supervision responsibility. We should fully understand the reform and innovation of the current drug regulatory system in the Drug Administration Law, study and study the new drug regulatory system, new methods and new contents in depth, promptly consult and report to the Party Committee and the government, communicate and communicate closely with relevant departments, and put forward new plans to improve drug regulatory work, in order to ensure drug regulatory work. It conforms to the latest requirements of the Drug Administration Law and meets the new expectations of the public for drug safety.

3、Strengthen the Foundation of Supervision and Promote the Modernization of Supervision System and Ability
The Drug Administration Law clarifies the status of technical institutions such as review, inspection, verification, monitoring and evaluation. It calls for strengthening the capacity building of review and approval and establishing a professional and professional team of inspectors.
 
      Each unit should take the opportunity of implementing the Drug Administration Law, further strengthen the construction of regulatory technical institutions, and improve the ability of examination, approval, inspection, monitoring and evaluation. In accordance with the "Opinions of the General Office of the State Council on the Establishment of Professional and Specialized Drug Inspectors" (No. 36, 2019 issued by the State Office), we should strengthen the construction of inspection institutions, rationally determine the size of the team, enrich the professional and specialized drug inspectors through multiple channels, strengthen professional training, establish a mechanism of discipline and supervision for inspectors, and accelerate the construction of the inspectors'team. Capacity-building.
 
       All regions should implement the requirement of local governments to take overall responsibility, report actively to local Party committees and governments, vigorously develop supervision science and technology under the unified leadership of Party committees and governments, continuously promote the modernization of drug supervision system and capacity, and consolidate the foundation of drug safety supervision.


4、Speed up the revision of supporting rules and regulations and establish a scientific and strict supervision system
 
       The Drug Administration Law calls for the establishment of a scientific and strict supervision and management system, and puts forward urgent requirements for the formulation and revision of supporting regulations, normative documents and technical guidelines of drug supervision and management departments. The State Pharmaceutical Regulatory Bureau conducts a thematic study on the preparation and revision of supporting regulations and documents and makes a clear deployment. In accordance with the target inversion schedule to be implemented before December 1, 2020, efforts are being made to revise the regulations on drug registration, post-marketing supervision and management, and to draft and revise relevant normative documents and technical guidelines. All localities should cooperate vigorously with the formulation and revision of relevant regulations and normative documents of the State Drug Administration and actively study and put forward suggestions for revision.

      All regions should earnestly sum up the experience of supervision and law enforcement, carefully study the problems of collaborative supervision under the system of drug market licensing holders, licensing and inspection of drug production and operation after GMP and GSP certification are cancelled, and the norms of discretion after administrative penalty is greatly increased, timely promulgate the implementation of the system rules, and earnestly prepare for the implementation of the law. Local governments are encouraged to formulate specific measures to ensure the effective implementation of the Drug Administration Law in light of local regulatory practices, laws, regulations and regulations as well as the provisions of the State Drug Administration.

5、Creating a good atmosphere for the implementation of the new law by innovating the ways and methods of popularizing the law
 
     The State Administration of Pharmaceutical Supervision will set up a "Drug Administration Law" propaganda mission, carry out a series of propaganda and itinerant propaganda activities, organize special training for local propaganda backbone, and strengthen the construction of local training teachers. Higher research institutes should play the role of the main channel of education and training of the State Drug Administration, integrate education and training resources, and organize training demonstration courses, special training courses and network training activities. Press centers, China Health Media Group and Southern Institute of Pharmacoeconomics should give full play to the advantages of media propaganda, innovate propaganda forms and means, and thoroughly interpret the important contents of the Drug Administration Law.
 
      All regions and units should organically combine the publicity of the Drug Administration Law with the ongoing publicity of the Vaccine Administration Law, integrate resources, innovate ways, expand channels and carry out all-round publicity of the Law. Focusing on the main responsibility of enterprises, focusing on the pertinence and effectiveness, we should increase the propaganda of drug research and development institutions and production and operation enterprises by means of centralized training, special lectures, on-site counseling, video answering, compiling manuals, and promoting consistency. We should guide enterprises to learn and understand the legal provisions, publicize and encourage innovative measures, and clarify the specific requirements of supervision. We should give full play to the role of newspapers, radio, movies, television, the Internet, mobile phones and other media. We should take the form of special columns, online interviews, expert interpretations, policy illustrations and micro-videos, and actively publicize the new system, measures, regulations and requirements of the Drug Administration Law, advocate social co-governance, and create the publicity of the Drug Administration Law. Good atmosphere for implementation.
 
     The State Administration of Pharmaceutical Supervision will give unified recognition to the units and individuals who have made outstanding achievements in the promulgation and implementation of the Drug Administration Law and the Vaccine Administration Law by the end of the year. All localities should take the opportunity of publicizing and implementing the Drug Administration Law and the Vaccine Administration Law, earnestly implement their regulatory responsibilities, strengthen supervision and law enforcement, severely crack down on drug safety violations, actively safeguard the drug safety of the broad masses, and celebrate the Seventieth Anniversary of the founding of New China with outstanding achievements.
 
                                                                State Drug Administration