echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Active Ingredient News > Drugs Articles > CFDA plans to issue the announcement on Further Strengthening the supervision of drug production process

    CFDA plans to issue the announcement on Further Strengthening the supervision of drug production process

    • Last Update: 2016-06-29
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Source: Dandelion 2016-06-29 content from: anonymous netizen note: This is just a draft, the official draft is subject to the final release of the National Bureau! It is hoped that this time the State Administration will give pharmaceutical enterprises an opportunity to make corrections and solve the problem of the inconsistency between the registration process and the actual process As a pharmaceutical manufacturer, this policy opportunity must not be let go! Announcement on Further Strengthening the supervision of drug production process according to the information of drug supervision and inspection, some drug manufacturing enterprises have the problem of not producing drugs according to the production process approved by the food and drug regulatory authorities In order to further standardize the drug production order and solve the problem that the drug manufacturing enterprises do not produce drugs according to the approved production process and do not study and apply for changing the production process according to the regulations, the relevant matters are hereby announced as follows: 1、 As the first person responsible for drug quality, drug manufacturing enterprises (including overseas pharmaceutical manufacturers, the same below) must organize production in strict accordance with the production process approved by the food and drug administration Since the date of this announcement, drug manufacturers shall carry out self inspection on the production process of each approved listed drug (the traditional Chinese medicine is the manufacturing method, the same below) to eliminate potential quality and safety hazards 2、 The content of self inspection is whether the actual production process of drugs is consistent with the production process approved by the food and drug administration The production processes approved by the food and drug administration include those approved when approving the drug production application and those approved when approving the relevant supplementary application 3、 According to the results of self-examination, the pharmaceutical manufacturers shall take the following measures (1) If the actual production process is consistent with the approved production process and can ensure the quality of drugs, the relevant drug manufacturing enterprises can continue to produce or import drugs and report the production process to the local provincial food and drug regulatory authorities for filing; the imported drug production process shall be reported to the administrative and reporting center of the food and Drug Administration (hereinafter referred to as the "Acceptance Center") for filing, and the Acceptance Center shall The application materials shall be submitted to the examination and inspection center of the food and drug administration within 5 days (2) If the actual production process is inconsistent with the approved production process, the production or import shall be stopped immediately Relevant pharmaceutical manufacturers shall carry out sufficient research and verification in accordance with the technical guidelines for research on change of listed traditional Chinese medicine (I), technical guidelines for research on change of listed chemical drugs (I), technical guidelines for management of change of production process of biological products and other relevant technical requirements 1 After research and verification, if the change of production process has no impact on the safety, effectiveness and quality controllability of drugs, the drug manufacturing enterprise shall report the production process and relevant data to the local provincial food and drug regulatory department for filing before continuing to produce, and the imported drug production process shall be reported to the acceptance center of the food and Drug Administration for filing before continuing to import The Acceptance Center shall, within 5 days after acceptance, submit the application materials to the examination and inspection center of the food and drug administration 2 After research and verification, if the change of production process has an impact on the safety, effectiveness and quality controllability of drugs, the drug manufacturer shall submit a supplementary application for "change of production process affecting the quality of drugs" in accordance with the requirements of Appendix 4 of the measures for the administration of drug registration The provincial food and Drug Administration or the acceptance and reporting center of the food and drug administration need not carry out on-site verification and sampling inspection after acceptance, and send the application materials to the drug review center of the State Food and drug administration within 5 days (hereinafter referred to as the "drug review center") The drug review center shall complete the technical review within 30 days after receiving the information, and may require the applicant to supplement the information if necessary, and the time required shall not be included in the time limit of the technical review The State Food and drug administration shall complete the administrative examination and approval within 5 days Only after the approval of the supplementary application can the drug manufacturer continue to produce or import drugs 4、 Drug manufacturers shall complete the above self inspection, research verification, filing or supplementary application before December 31, 2016; if they fail to complete them on time, production or import shall be suspended The production process filing of domestic drugs and imported drugs shall be submitted in accordance with item 36 and Item 18 of the supplementary application items in Annex 4 to the measures for the administration of drug registration See Annex 1 for the requirements of application materials 5、 From March 1, 2017, the State Food and Drug Administration will organize experts to carry out flight inspection on drug manufacturers If the actual production process is found to be inconsistent with the production process filed or approved by the food and drug administration, the drugs produced shall be punished as fake drugs, and shall be punished in accordance with the relevant provisions of Article 73 of the drug administration law of the people's Republic of China, and the legal representative and relevant responsible personnel of the relevant drug production enterprises shall be opened to the public 6、 According to the technical guidelines for change research of listed traditional Chinese medicine (I), technical guidelines for change research of listed chemical drugs (I), technical guidelines for change management of production process of biological products, changes that do not affect safety, effectiveness and quality controllability mainly include traditional Chinese medicine and chemical drugs I Class II and class II changes, class III changes of biological products The changes affecting safety, effectiveness and quality controllability mainly include the changes of traditional Chinese medicine and chemicals in category III, biological products in Category I and II, etc See Annex 2 for details It is hereby announced Annex 1: requirements for filing and application materials of pharmaceutical production process Annex 2: change of pharmaceutical production process form of food and Drug Administration June 2016
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.