Announcement on the work of the production process of drug production

 

  (Draft for Opinion)

 

  Drug production process is the process and method of continuously and stable production of qualified drugs，Production of production process organization approved by the regulatory authorities is the prerequisite for ensuring the quality of drugs。To strengthen the management of drug production technology，The former National Food and Drug Administration deployed in August 2007 and carried out the production process and prescription verification work of injection category，Provincial bureaus reviewed related information such as the production process and registered production process of enterprises，Preliminary establishment of data files such as injection production process。The "Administrative Measures for the Registration of Drug Registration" revised and implemented in October 2007 stipulate，The feasibility of ensuring the production process approved by the technical review department，The actual production process of most drugs that have been approved since then is consistent with the approved production process。In recent years，Food and Drug Supervision stake betting appDepartment found in the supervision and inspection of some varieties that were still approved by 2007 to be produced in accordance with the approval production process、Change the production process does not study and declare as required。For this，The General Administration decided to carry out the check -up work of drug production technology。The relevant matters are announced as follows:

 

  a、The main responsibility of drug production enterprises assume drug quality and safety，It must be produced in strict accordance with the production process organization approved by the food and drug supervision department。Drug production enterprises change approved production technology，Must be sufficient research and verification，and submit a supplementary application for drug registration in accordance with the relevant provisions of the "Administrative Measures for the Registration of Drugs"。

 

  2、From the date of the announcement of this announcement，Drug production enterprises should respond to the production technology of each approved listing of drugs (Chinese medicine as the system，Same below) Carry out self -examination，Eliminate hidden dangers of quality and safety。

 

  3、The actual production process of the self -inspection content is the drug with the drug and the production process approved by the food and drug supervision department。The production process approved by the Food and Drug Supervision Department includes the production process approved by the application for the application of drug production and the production process approved by the replenishment of supplementary applications。

 

  4、Drug production enterprises should complete self -examination before October 1, 2016 and will report self -inspection to the provincial food and drug supervision department where the self -check situation is located。Provincial food and drug supervision departments shall summarize in response to the company's self -inspection situation，Fill in the Self -Check Summary Table (Annex 1) and report to the State Administration of Food and Drugs before November 1, 2016。

 

  5、Drug production enterprises based on self -examination results，The following treatment measures should be taken respectively:

 

  stake sports betting app(1) The actual production process is consistent with the approval production process、It can guarantee the quality of the medicine，Pharmaceutical manufacturers should be filled in the self -examination report with the drug production process and other information，Carry out daily supervision as a regulatory authorities、Preparation information for on -site inspection。

 

  (2) If the actual production process is inconsistent with the approval production process，Related drug manufacturers should supplement the application matters in accordance with the "Regulations on the Management of Quality Management of Drug Production" and "Measures for the Management of Drug Registration" and the "Principles of the Principles of Research in Traditional Chinese Medicine Research (1)", "Principles of Research in Chinese Medication (1)", "Research on the Change of Chemicals for Listed P China, Technical Guidance Principles (I) "" "Institutional Guidance Principles of Biological Product Production Process Management Process" and other related technical requirements to carry out full research and verification。

 

  Research and verification，The change in production process changes on the quality of the medicine，Drug production enterprises shall apply for supplementary applications in accordance with the "Administrative Measures for Drug Registration"，See Annexes 2。Provincial Food and Drug Supervision Department will submit the application information to the State Food and Drug Administration Drug Review Center (hereinafter referred to as & ldquo; Drug Review Center & rdquo;)。Drug Examination Center carried out technical reviews in accordance with the "Administrative Measures for Drug Registration"，If necessary, you can ask the applicant to supplement the information，The time required for the technical review time limit。The State Administration of Food and Drug Supervision and Administration made an approval decision in accordance with the "Administrative Measures for the Registration of Drugs"。

 

  Research and verification，Changes in production processes affect the quality of drugs，Enterprises should discontinue production immediately。Drug production enterprises shall propose & ldquo in accordance with the "Administrative Measures for the Registration Stake Sports Bettingof Drugs".。Provincial food and drug regulatory authorities will report the application information to the drug review center within 5 days after acceptance。Drug Examination Center shall organize special review forces、Establish a separate review channel，Complete technical review within 30 days after receiving the application information，If necessary, you can ask the applicant to supplement the information，The time required for the technical review time limit。The State Food and Drug Administration should complete administrative approval within 5 days。After the application is approved，Drug manufacturers can continue to produce。

 

  Drug production enterprises shall complete the research and verification of the product species production process before June 30, 2017、Submit related work such as supplementary applications，Other non -production species shall complete the above work before December 31, 2017; if it is not completed on time，Stop production。

 

  6、From November 1, 2016，The State Food and Drug Administration will organize experts to conduct flight inspections on drug production enterprises。During the inspection, it was found that the actual production process is inconsistent with the production process approved by the food and drug regulatory authorities，According to the relevant provisions of Article 48 of the Drug Administration Law of the People's Republic of China，The medicines produced by the fake medicine theory。The drug supervision department will punish drug manufacturers involved in accordance with Article 74 of the Drug Administration Law of the People's Republic of China，and disclose the legal representatives and relevant responsible persons of related enterprises to the society。

 

  Seven、Change of production process that has affected the quality of drugs，But the manufacturer can ensure the safety and effective product，The following situation，You can stop production for a while，However。

 

  (1) Related varieties before the implementation of the "Measures for the Administration，It has been normally produced since then，The production process is stable and no problem of safety and effectiveness;

 

  (2) Related varieties of production processes affecting the quality of drugs，The change after My stake betting appthe change is technical progress or innovation。

 

  eight、This announcement is implemented from the date of issuance，Imported drugs refer to execution。

 

  Feeling announcement.