Notice of the General Office of the State Administration of Food and Drug Administration on Matters concerning the Implementation of the Newly Revised Regulations on the Quality Management of Pharmaceutical Production


Release time:

2013-12-31

The Food and Drug Administration of all provinces, autonomous regions and municipalities directly under the Central Government, and the Food and Drug Administration of Xinjiang Production and Construction Corps: The State Food and Drug Administration has issued the Announcement on Matters Related to the Implementation of the "Pharmaceutical Production Quality Management Standards (Revised in 2010)" for Sterile Drugs (No. 53 of 2013, hereinafter referred to as the "Announcement"). In order to ensure the implementation of the requirements of the Announcement, the relevant matters are hereby notified as follows: All localities in the 1. must earnestly implement the requirements of the "Announcement". All sterile drug manufacturers or production workshops that have not passed the certification of blood products, vaccines, injections, etc., must stop production from January 1, 2014. All localities are requested to immediately notify the enterprises that have not passed the GMP certification of drugs to stop drug production activities in accordance with the requirements of the Announcement. all localities in the 2. should strengthen supervision and inspection of enterprises or production workshops that should stop production within their administrative regions. The food and drug administrations of all counties (cities and districts) shall comprehensively sort out the enterprises that have stopped production and conduct on-site inspection one by one to confirm the suspension status. The food and drug administrations of all provinces (autonomous regions and municipalities) shall summarize the suspension of production and inspection (see annex for the summary form) and report to the drug and cosmetics supervision department of the general administration before January 10, 2014. At the same time, we should pay close attention to the situation of enterprises that have stopped production, and those who fail to stop production in accordance with the regulations should be investigated and dealt with in accordance with the "the People's Republic of China and Drug Administration Law" and relevant regulations. All parts of the 3. should closely monitor the raw materials and packaging materials of the enterprises that have stopped production, and take effective control measures. In particular, it is necessary to strengthen the supervision and management of the original and auxiliary materials of special drug manufacturers such as narcotic drugs, psychotropic drugs, toxic drugs for medical use, and radioactive drugs that have stopped production, and take strict control measures and affil seals to prevent them from flowing into illegal channels and bringing harm to society. All localities of the 4. should pay close attention to the various situations that may occur after the suspension of production of enterprises, and promptly study and judge and report the drug shortage in a timely manner; promptly respond to and properly handle the problems reported by the media, public concern, and medical institutions; for the suspension of production The social stability and other issues that may arise in enterprises must be reported to the local government in a timely manner and reported to the General Administration at the same time. All localities in the 5. should unify their thinking, raise awareness, and earnestly implement the requirements of the "Announcement. In the process of implementation, if any new problems are found, they shall be reported to the drug and cosmetics supervision department of the general administration in a timely manner. Contact: Cui Hao Tel: 010-88330842,88330852 (fax) Annex: Summary of Production Stop and Inspection of Sterile Drug Production Enterprises or Workshops General Office of China Food and Drug Administration December 31, 2013