Food and Drug Administration in each province, autonomous region and municipality and Food and Drug Administration of Xinjiang Production and Construction Corps,
In accordance with the Decision of the CPC Central Committee on Deepening the Reform of the Party and State Institutions, Circular of the State Council on Establishment of Institutions, and Circular of the State Council on the Setup of National Bureaus Administrated by Ministries and Commissions, China Drug Administration is established and administered by SMRA. The China Food and Drug Administration will no longer be retained. In order to ensure the smooth and orderly supervision of drugs (including medical devices and cosmetics, the same below) and the drug safety during the institutional reform, relevant requirements are hereby notified as follows:
1. Deeply realize the importance of institutional reform. Deepening of the reform of the Party and state institutions is a major measure to thoroughly implement the spirits of 19th CPC National Congress and is an important task in advancing the modernization of the governance system and governance capabilities. All localities shall fully understand the necessity and importance of the reform of the Party and state institutions from the perspective of politics and the overall situation, and unify their understanding and thinking with the decisions of the CPC Central Committee on deepening the reform of the Party and state institutions, and enhance the “Four Consciousness, firmly believe in “Four Confidence" and firmly uphold the authority of the CPC Central Committee and its centralized and unified leadership with Comrade Xi Jinping at the core, and implement the decision-making and deployment of the CPC Central Committee. During the period of institutional reform, effectively carry out ideological and political work, stabilize the drug supervision and management teams, and ensure correct ideology view, stable teams, hardworking and passion for work.
2. Make every effort to ensure the continuity of drug supervision. The food and drug regulatory authorities at all levels shall firmly establish “Four Consciousness” and strengthen responsibility, abide by the unified deployment arrangements of the local party committees and governments, adjust the drug regulatory function, straighten out relationship, and ensure the normal operation of work. Prior to the adjustment of institutional functions is completed, all matters including administrative licensing, supervision and inspection, inspection and detection, law enforcement, complaint reporting, and information disclosure related to drugs shall be handled in accordance with the original provisions before the introduction of new rules and regulations. The current procedures for the application, acceptance, verification, and approval of drug administrative licenses, as well as the format of certificates, the format of documents, and business seals, shall remain unchanged to ensure the continuity of daily work.
3. Strengthen the daily supervision of drugs. The food and drug regulatory authorities at all levels shall adhere to the “Four Strictest” requirements, persist in problem-oriented and strengthen daily supervision, strengthen the on-site inspection of drug production and operation enterprises, and focus on checking the implementation of risk responsibility, the implementation of production and operation quality management specifications, and the data for authenticity, integrity and reliability, and implement main responsibility of enterprises. Focus on investigating and handling major cases, crack down on various types of violations of laws and regulations, such as the adulterated Chinese herbal medicines, the illegal sale of drugs on the Internet and in urban and rural areas, and prevent the systematic or regional drug safety incidents from happening.
4. Continue to intensify the reform of drug and medical devices review and approval system The food and drug regulatory authorities at all levels shall continue to implement the Opinions On Deepening Reform of Review and Approval System and Encouraging Innovation of Drug and Medical Device (TZ [2017] No. 42) issued by the General Office of the CPC Central Committee and the General Office of the State and carry out the reform. All localities shall, in accordance with the established work arrangements at the beginning of the year, continuously improve the reform supporting policies and measures, speed up the establishment of a modern review and inspection system, and promote the implementation of key reform tasks such as the establishment of drugs and devices category file, and the consistency evaluation of quality and efficacy of generic drugs, improve work efficiency and quality, and promote the development of high-quality drugs and devices.
5. Correctly guide public opinion to create a good atmosphere. Pay great attention to the drug safety. During the period of institutional reform, food and drug regulatory authorities at all levels shall strengthen monitoring and evaluation of public opinion, respond positively to social concerns, properly handle hot issues and public opinion cases, and prevent public opinion from being hyped. Innovate the means of communication, expand the channels for propaganda, strengthen the science popularization and propaganda of drug safety, and create a favorable public opinion environment. Increase the disclosure of government affairs information, disclose the regulatory and enforcement information in a timely manner, expose violations in a timely manner, and constantly improve the transparency of regulation. Open the channels for complaints reporting, and encourage consumers to report complaints to work together for drug safety.
6. Fully implement the responsibility of territorial management
The local people's governments at all levels shall earnestly fulfill the responsibilities for drug safety management, strengthen organization and leadership, strengthen overall coordination, prevent major drug safety problems from occurring in the administrative regions, and create a favorable environment for the smooth implementation of institutional reform. Food and drug regulatory authorities at all levels shall integrate duties adjustments with the daily work, and perform official duties in accordance with the law, and ensure the drug safety. Report major problems in a timely manner.
In accordance with the Decision of the CPC Central Committee on Deepening the Reform of the Party and State Institutions, Circular of the State Council on Establishment of Institutions, and Circular of the State Council on the Setup of National Bureaus Administrated by Ministries and Commissions, China Drug Administration is established and administered by SMRA. The China Food and Drug Administration will no longer be retained. In order to ensure the smooth and orderly supervision of drugs (including medical devices and cosmetics, the same below) and the drug safety during the institutional reform, relevant requirements are hereby notified as follows:
1. Deeply realize the importance of institutional reform. Deepening of the reform of the Party and state institutions is a major measure to thoroughly implement the spirits of 19th CPC National Congress and is an important task in advancing the modernization of the governance system and governance capabilities. All localities shall fully understand the necessity and importance of the reform of the Party and state institutions from the perspective of politics and the overall situation, and unify their understanding and thinking with the decisions of the CPC Central Committee on deepening the reform of the Party and state institutions, and enhance the “Four Consciousness, firmly believe in “Four Confidence" and firmly uphold the authority of the CPC Central Committee and its centralized and unified leadership with Comrade Xi Jinping at the core, and implement the decision-making and deployment of the CPC Central Committee. During the period of institutional reform, effectively carry out ideological and political work, stabilize the drug supervision and management teams, and ensure correct ideology view, stable teams, hardworking and passion for work.
2. Make every effort to ensure the continuity of drug supervision. The food and drug regulatory authorities at all levels shall firmly establish “Four Consciousness” and strengthen responsibility, abide by the unified deployment arrangements of the local party committees and governments, adjust the drug regulatory function, straighten out relationship, and ensure the normal operation of work. Prior to the adjustment of institutional functions is completed, all matters including administrative licensing, supervision and inspection, inspection and detection, law enforcement, complaint reporting, and information disclosure related to drugs shall be handled in accordance with the original provisions before the introduction of new rules and regulations. The current procedures for the application, acceptance, verification, and approval of drug administrative licenses, as well as the format of certificates, the format of documents, and business seals, shall remain unchanged to ensure the continuity of daily work.
3. Strengthen the daily supervision of drugs. The food and drug regulatory authorities at all levels shall adhere to the “Four Strictest” requirements, persist in problem-oriented and strengthen daily supervision, strengthen the on-site inspection of drug production and operation enterprises, and focus on checking the implementation of risk responsibility, the implementation of production and operation quality management specifications, and the data for authenticity, integrity and reliability, and implement main responsibility of enterprises. Focus on investigating and handling major cases, crack down on various types of violations of laws and regulations, such as the adulterated Chinese herbal medicines, the illegal sale of drugs on the Internet and in urban and rural areas, and prevent the systematic or regional drug safety incidents from happening.
4. Continue to intensify the reform of drug and medical devices review and approval system The food and drug regulatory authorities at all levels shall continue to implement the Opinions On Deepening Reform of Review and Approval System and Encouraging Innovation of Drug and Medical Device (TZ [2017] No. 42) issued by the General Office of the CPC Central Committee and the General Office of the State and carry out the reform. All localities shall, in accordance with the established work arrangements at the beginning of the year, continuously improve the reform supporting policies and measures, speed up the establishment of a modern review and inspection system, and promote the implementation of key reform tasks such as the establishment of drugs and devices category file, and the consistency evaluation of quality and efficacy of generic drugs, improve work efficiency and quality, and promote the development of high-quality drugs and devices.
5. Correctly guide public opinion to create a good atmosphere. Pay great attention to the drug safety. During the period of institutional reform, food and drug regulatory authorities at all levels shall strengthen monitoring and evaluation of public opinion, respond positively to social concerns, properly handle hot issues and public opinion cases, and prevent public opinion from being hyped. Innovate the means of communication, expand the channels for propaganda, strengthen the science popularization and propaganda of drug safety, and create a favorable public opinion environment. Increase the disclosure of government affairs information, disclose the regulatory and enforcement information in a timely manner, expose violations in a timely manner, and constantly improve the transparency of regulation. Open the channels for complaints reporting, and encourage consumers to report complaints to work together for drug safety.
6. Fully implement the responsibility of territorial management
The local people's governments at all levels shall earnestly fulfill the responsibilities for drug safety management, strengthen organization and leadership, strengthen overall coordination, prevent major drug safety problems from occurring in the administrative regions, and create a favorable environment for the smooth implementation of institutional reform. Food and drug regulatory authorities at all levels shall integrate duties adjustments with the daily work, and perform official duties in accordance with the law, and ensure the drug safety. Report major problems in a timely manner.
China Drug Administration
April 9, 2018
April 9, 2018