The General Office of the General Administration publicly solicited the meaning of the Announcement on the Implementation of the Drug Production Process Check (Draft for Comments):

In order to further standardize the management of drug production processes and ensure the safety of public drug use, the General Administration of Food and Drug Administration has organized and drafted the Bulletin on the Implementation of the Review of Drug Production Processes (Draft for Comments), which is now open to the public for comments. Please email your amendments to the Drug and Cosmetics Registration and Administration Department of the General Administration of Food and Drug Administration by September 10, 2016.
Contact: Xue Yanju
E-mail:
yhzcszhc@cfda.gov.cn
Announcement on the implementation of drug production process check work (draft for comments)
Drug production process is a continuous and stable production of qualified drugs process and methods, in accordance with the regulatory approval of the production process organization production is to ensure the quality of drugs prerequisite. In order to strengthen the management of drug production process, the former State Food and Drug Administration deployed in August 2007 to carry out the production process of injectable drugs and prescription verification work, the provincial bureaus of enterprises declared and registered production process and other relevant information review, the initial establishment of injection production process and other information files. The Measures for the Administration of Drug Registration, as amended and implemented in October 2007, stipulate that on-site inspection of approved drugs should be carried out before they are approved for market, which guarantees the feasibility of the production process approved by the technical review department, and the actual production process of the vast majority of the drugs approved for listing thereafter is consistent with the approved production process. In recent years, the food and drug regulatory department in the supervision and inspection found that there are still some approved before 2007 listed varieties did not organize production in accordance with the approved production process, change the production process does not study and declare according to regulations. To this end, the General Administration decided to carry out drug production process checking work. The relevant matters are announced as follows:
. Pharmaceutical production enterprises bear the main responsibility for drug quality and safety, and must organize production in strict accordance with the production process approved by the food and drug regulatory authorities. Pharmaceutical production enterprises to change the approved production process, must go through adequate research and verification, and in accordance with the relevant provisions of the Measures for the Administration of Drug Registration to submit a supplementary application for drug registration.
the date of this announcement, pharmaceutical production enterprises shall conduct self-examination and eliminate the hidden dangers of quality and safety in the production process of each approved listed drug (Chinese medicine as the method, the same as between relevant).
, self-examination content of the actual production process of drugs and reported to the food and drug regulatory authorities approved the production process is consistent. The production process approved by the food and drug regulatory department includes the production process approved when the application for drug production is approved and the production process approved when the relevant supplementary application is approved.
, pharmaceutical production enterprises shall complete their self-examination by October 1, 2016 and report the self-examination to the provincial food and drug regulatory departments where they are located. The provincial food and drug regulatory departments shall summarize the self-examination of enterprises, fill out the summary form of self-examination (Annex 1) and report it to the General Administration of Food and Drug Administration by November 1, 2016.
5. According to the results of self-examination, pharmaceutical production enterprises shall take the following treatment measures respectively:
(1) If the actual production process is consistent with the approved production process and can guarantee the quality of the drug, the pharmaceutical production enterprise shall file the self-examination report together with the information of the drug production process, and act as the reference data for daily supervision and on-site verification by the regulatory authorities.
(2) If the actual production process is inconsistent with the approved production process, the relevant pharmaceutical production enterprises shall carry out full research and verification in accordance with the relevant requirements of the Drug Registration Management Code for The relevant applications and the technical guidelines for the research on the change of listed Chinese medicines (I) and the technical guidelines for the change of listed chemicals (1) and the technical guidelines for the management of changes in the biological products production process.
if, after research and verification, changes in the production process have no effect on the quality of medicines, pharmaceutical production enterprises shall apply for additional applications in accordance with Item 18 of Annex 4 of the Measures for the Administration of Drug Registration, and the requirements for declaration of information shall be set out in Annex 2. The provincial food and drug regulatory department shall, within 5 days after acceptance, send the declaration information to the Drug Review Center of the State Food and Drug Administration (hereinafter referred to as the "Drug Review Center"). The Drug Review Center shall conduct a technical review in accordance with the Measures for the Administration of Drug Registration and may, if necessary, request additional information from the applicant, and the time required shall not be included in the time limit for the technical review. The State Administration of Food and Drug Administration shall make an examination and approval decision in accordance with the Measures for the Administration of Drug Registration.
, the production process changes have an impact on the quality of drugs, enterprises should immediately stop production. Pharmaceutical production enterprises shall, in accordance with Article 7 of Annex 4 to the Measures for the Administration of Drug Registration, make supplementary applications for "changes in production processes affecting the quality of medicines". The provincial food and drug regulatory department shall send the declaration data to the drug audit center within 5 days after acceptance. The Drug Audit Center shall organize a special review force, establish a separate review channel, complete the technical review within 30 days after receiving the declared information, and, if necessary, request additional information from the applicant, the time required shall not be included in the time limit for the technical review. The State Administration of Food and Drug Administration shall complete the administrative examination and approval within 5 days. After the supplementary application is approved, the pharmaceutical production enterprise may continue to produce.
pharmaceutical production enterprises shall complete the research verification and submission of supplementary applications in the production process of the product species by June 30, 2017, and other discontinued varieties shall complete the above work by December 31, 2017;
, November 1, 2016, the State Administration of Food and Drug Administration will organize experts to carry out flight inspections of pharmaceutical manufacturers. If the actual production process is found to be inconsistent with the production process approved by the food and drug regulatory department, the drugs produced shall be treated as counterfeit medicines in accordance with the relevant provisions of Article 48 (2) of the Drug Administration Law of the People's Republic of China. The drug regulatory department shall, in accordance with the relevant provisions of Article 74 of the Drug Administration Law of the People's Republic of China, punish the pharmaceutical production enterprises involved, and disclose to the public the legal representatives and relevant responsible personnel of the relevant enterprises.
, there have been changes in the production process affecting the quality of drugs, but the production enterprises can ensure that the product is safe and effective, in accordance with the following conditions, may not stop production, but need to make relevant supplementary applications in accordance with the requirements of this announcement.
(1) The relevant varieties have underlyed changes in the production process affecting the quality of the drug before the 2007 revision and implementation of the Measures for the Administration of Drug Registration, and have been in normal production since then, the production process is stable and no safety and effectiveness problems have been found;
(2) the relevant varieties have changed the production process affecting the quality of the drug, and the changed production process is technological progress or innovation.
, this announcement shall be implemented from the date of publication, and imported drugs shall be carried out by reference.
this announcement. (State Administration of Food and Drug Administration)