Do you know how diligent this administration of CFDA is? People in the pharmaceutical circle have led the good life of "see you on Friday" after Minister Bi (Jingquan) took office, namely, there is major policy introduced on every Friday, however, we are too young after all, as CFDA is more diligent than we think: it was just Thursday, but CFDA already introduced another major policy on APIs.
CFDA issued the Announcement on Adjusting Matters Concerning the Review and Approval of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Excipients and Pharmaceutical Packaging Materials on its website on November 30, to cancel the approval of pharmaceutical excipients and packaging materials and containers in direct contact with pharmaceutical products (hereinafter referred to as the pharmaceutical packaging materials), and conduct review and approval of APIs, pharmaceutical excipients, and pharmaceutical packaging materials together at the time of approval of registration applications of pharmaceutical preparations. Those few words declare the formal end of the era of API approval numbers, and the arrival of the DMF filing system!!!
Announcement of the CFDA on Adjusting Matters Concerning the Review and Approval of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Excipients and Pharmaceutical Packaging Materials (No. 146, 2017)
Issued on November 30, 2017
See the "Announcement of the CFDA on Adjusting Matters Concerning the Review and Approval of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Excipients and Pharmaceutical Packaging Materials (No. 146, 2017) http://www.sda.gov.cn/WS01/CL0087/217747.html" of CFDA website for details of the announcement. Next, I will summarize this announcement from scope of application, measures for the implementation, scheme for transitional period, special circumstances, and liability subjects and information change.
Scope of application: Requirements of this Announcement apply to the APIs which are used in the applications filed by pharmaceutical product registration applicants within the territory of China for pharmaceutical preparations under registration Categories 2.2, 2.3, 2.4, 3, 4 and 5, and to pharmaceutical excipients and pharmaceutical packaging materials which are used in registration applications of various pharmaceutical products.
Measures for the implementation: From the date when this Announcement is issued, food and drug administrations at all levels will no longer accept separate applications for registering APIs, pharmaceutical excipients and pharmaceutical packaging materials, and the Center for Drug Evaluation under the CFDA (hereinafter referred to as the CDE) will develop a platform (hereinafter referred to as the registration platform) and a database for the registration of APIs, pharmaceutical excipients and pharmaceutical packaging materials. Relevant enterprises or entities may submit registration data for APIs, pharmaceutical excipients and pharmaceutical packaging materials through the registration platform, pursuant to requirements in this Announcement, in order to obtain the registration numbers of APIs, pharmaceutical excipients and pharmaceutical packaging materials. These APIs, pharmaceutical excipients and pharmaceutical packaging materials in question will be reviewed together with the related pharmaceutical preparations after applications have been filed for registering such preparations.
Scheme for transitional period:
During the transitional period of establishment of the registration platform, the CDE will publicize the "API registration data", "pharmaceutical excipient registration data", and "pharmaceutical packaging material registration data" to the society in the form of sheet on its portal website (www.cde.org.cn).
(1) For the registration applications of APIs, pharmaceutical excipients and pharmaceutical packaging materials...
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