State Food and Drug Administration: implement and study the drug management law, and explicitly cancel GMP certification and GSP certification for the first time.

Drug administration of all provinces, autonomous regions and municipalities directly under the central government, drug administration of Xinjiang production and Construction Corps, all departments, bureaus and units directly under the Bureau: The drug administration law of the people's Republic of China (hereinafter referred to as the drug administration law) was deliberated and adopted at the 12th meeting of the Standing Committee of the 13th National People's Congress on August 26, 2019, and shall come into force on December 1, 2019 In order to study, publicize and implement the drug administration law, we hereby give the following notice on relevant matters: first, deeply understand the purpose and spirit of legislation, fully understand the significance of publicity and implementation of the drug administration law, drug safety is related to the vital interests of the general public and the overall situation of economic and social development The CPC Central Committee and the State Council attached great importance to the work of drug safety General Secretary Xi Jinping and Premier Li Keqiang made important instructions on several occasions, calling for speeding up the long-term mechanism of vaccine and drug supervision and improving laws, regulations and rules The revision of the drug administration law will fully implement the decision-making and deployment of the central government and the "four strictest" requirements, boost reform with legislation, safeguard the people's livelihood with the rule of law, strengthen drug management, ensure drug quality, safeguard the safety and legitimate rights and interests of the public in drug use, and protect and promote public health It will play an important role in protecting the rights and interests of the public in drug use and encouraging the innovation and development of industry Its important role All regions and units should take the spirit of the 19th National Congress of the Communist Party of China and the second and third plenary sessions of the 19th Central Committee of the Communist Party of China as the guidance, insist on taking the people as the starting point and the foothold, fully implement the spirit of the important instructions and instructions of the CPC Central Committee and the State Council on drug safety supervision, firmly safeguard the vital interests of the masses, and fully understand the promotion and implementation of the drug management law The importance and necessity shall be strengthened, the sense of responsibility and mission shall be strengthened, the organization and leadership shall be strengthened, the work tasks shall be defined, the work responsibilities shall be implemented, the funding guarantee shall be strengthened, the supervision and assessment shall be strictly carried out, and the study, publicity and Implementation of the drug administration law shall be actively carried out 2、 Grasp the basic principles and key contents to ensure the effective implementation of new systems The drug administration law makes it clear that drug administration should focus on people's health, adhere to the principles of risk management, whole process control and social co governance, and focus on the requirements of encouraging innovation and full life cycle management, make a number of major institutional innovations, such as drug listing license holders, drug traceability, drug vigilance, unified release of drug safety information, punishment to people, etc., to research, develop, register and improve the quality of drugs Comprehensive provisions shall be made on production, operation, use, post marketing management, drug price and advertisement, reserve and supply, supervision and management, legal liability, etc Strengthen the dynamic supervision, cancel the GMP certification and GSP certification, and the drug supervision and administration department shall check the implementation of GMP and GSP at any time We will improve the system of responsibility for drug safety, strengthen supervision during and after the event, pay more attention to rectifying disorder, and severely punish and 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 contact with the actual situation, deeply understand the basic principles of the drug administration law, and 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, implementation of regulatory responsibility and other key contents 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 in combination with the regulatory authority and the actual situation of the jurisdiction, ask for instructions and report to the Party committee and the government in a timely manner, closely communicate and exchange with relevant departments, propose new plans to improve drug regulatory work, and ensure all drug regulatory work Meet the latest requirements of drug administration law and meet the new expectations of public drug safety 3、 The pharmaceutical administration law defines the status of technical institutions such as review, inspection, verification, monitoring and evaluation, and calls for strengthening the capacity-building of review and approval, and establishing a professional and professional team of inspectors All units should take the implementation of the drug administration law as an opportunity to further strengthen the construction of regulatory technical institutions, and improve the capacity of review and approval, inspection, verification, monitoring and evaluation In accordance with the opinions of the general office of the State Council on the establishment of a professional team of drug inspectors (GBF [2019] No 36), we should strengthen the construction of inspection institutions, reasonably determine the size of the team, enrich the team of professional and professional drug inspectors through various channels, strengthen business training, establish a discipline and supervision mechanism for inspectors, and accelerate the construction of the team of inspectors Capacity building All regions should implement the requirements of the local government's overall responsibility, actively report to the local Party committee and government, under the unified leadership of the Party committee and government, vigorously develop regulatory science and technology, continuously promote the modernization of drug regulatory system and regulatory capacity, and consolidate the basis of drug safety supervision 4、 We will speed up the revision of supporting rules and regulations, establish a scientific and strict regulatory system, which is required by the drug administration law, and put forward urgent requirements for the revision of supporting rules, normative documents and technical guidelines of drug regulatory authorities The State Food and Drug Administration conducts a special study on the preparation and revision of supporting regulations and documents, and makes a clear deployment In accordance with the target inverted schedule implemented before December 1, 2020, we are speeding up the drafting and revision of regulations and relevant normative documents and technical guidelines, such as measures for the administration of drug registration and post marketing supervision All localities should vigorously cooperate with the State Food and Drug Administration in the formulation and revision of relevant regulations and normative documents, and actively study and put forward suggestions for revision All regions should conscientiously summarize the experience of supervision and law enforcement, carefully study the problems such as collaborative supervision under the system of drug listing license holders, license and inspection of drug production and operation after the cancellation of GMP and GSP certification, and the regulation of discretion after the substantial increase of administrative penalty, timely issue the implemented system rules, and effectively prepare for the implementation of the law All localities are encouraged to formulate specific measures according to local conditions, in accordance with laws and regulations and the provisions of the State Food and drug administration, to clarify the implementation requirements, and to ensure the effective implementation of the drug administration law 5、 To create a good atmosphere for the implementation of the new law, the State Food and Drug Administration will set up a propaganda group for the drug administration law, carry out a series of activities such as propaganda and itinerant propaganda, organize special training for local backbone propaganda, and strengthen the construction of local training teachers Institutes of higher learning should give full play to the role of the State Food and drug administration as the main channel of education and training, integrate education and training resources, and hold a series of activities such as training demonstration courses, special training courses and online training The information center, China health media group and Nanfang pharmaceutical economic research institute should give full play to the advantages of media publicity, innovate the forms and means of publicity, and thoroughly interpret the important contents of the drug administration law All regions and units should organically combine the publicity of drug administration law with the ongoing publicity of vaccine administration law, integrate resources, innovate ways, expand channels, and carry out all-round publicity of drug administration law We should focus on the main responsibility of the enterprise, highlight the pertinence and effectiveness, take various methods such as centralized training, special explanation, door-to-door guidance, video Q & A, preparation of manuals, supervision and implementation, increase the publicity of drug research and development institutions and production and operation enterprises, guide the enterprise to learn and understand the legal provisions, publicize and encourage innovation measures, and clarify the specific requirements of supervision We should give full play to the role of newspapers, radio, films, television, the Internet, mobile phones and other media, take the form of special columns, online interviews, expert interpretation, policy illustrations, micro videos and other popular forms, take the initiative to publicize the new system, new measures, new regulations and new 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 Food and Drug Administration will give a unified commendation to the units and individuals who have made outstanding achievements in the publicity and implementation of drug administration law and vaccine administration law by the end of this year All localities should take the opportunity of publicizing and implementing the drug administration law and vaccine administration law, conscientiously implement regulatory responsibilities, strengthen regulatory law enforcement, severely crack down on drug safety violations, actively safeguard the drug safety of the masses, and celebrate the 70th anniversary of the founding of new China with outstanding achievements SFDA September 19, 2019