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 that have been accepted but not completed review and approval, the CDE will generate the registration numbers of APIs, pharmaceutical excipients and pharmaceutical packaging materials, and publicize the above registration data sheets to the society after importing the application information to them. Applicants shall submit the application and registration data to the CDE in the form of CD according to requirements of this Announcement;
(2) For the newly applied pharmaceutical preparations (including supplementary applications to change the APIs, pharmaceutical excipients and pharmaceutical packaging materials) that use APIs, pharmaceutical excipients and pharmaceutical packaging materials already having approval numbers, such APIs, pharmaceutical excipients and pharmaceutical packaging materials shall also be registered as required;
(3) The relevant registration requirements for APIs, pharmaceutical excipients and pharmaceutical packaging materials that have received approval numbers before issuance of this Announcement will be separately notified after establishment of the registration platform.
Special circumstances:
(1) The APIs, pharmaceutical excipients and pharmaceutical packaging materials of the pharmaceutical preparation applicants for self-use only, or those specially supplied for the use of specific Marketing Authorization Holders can be omitted registration when the data of APIs, pharmaceutical excipients and pharmaceutical packaging materials are also submitted in the pharmaceutical preparation applications.
(2) Pharmaceutical preparation applicants may select the APIs, pharmaceutical excipients and pharmaceutical packaging materials that already have registration numbers for research, to file marketing applications or change applications of APIs, pharmaceutical excipients and pharmaceutical packaging materials. If the applicants for pharmaceutical preparations and APIs, pharmaceutical excipients and pharmaceutical packaging materials are not the same, the pharmaceutical preparation applicants shall provide the letter of authorization of the Marketing Authorization Holders or enterprises of the APIs, pharmaceutical excipients and pharmaceutical packaging materials in the application data;
Liability subjects:
Pharmaceutical preparation applicants shall be responsible for the quality of the APIs, pharmaceutical excipients and pharmaceutical packaging materials selected, fully research and assess the impacts of changes of APIs, pharmaceutical excipients and pharmaceutical packaging materials on their products, conduct research according to relevant provisions and guiding principles of the CFDA, and file change applications or conduct filing as required.
Provincial food and drug administrations shall be responsible for daily supervision and management of the manufacturing enterprises of APIs, pharmaceutical excipients and pharmaceutical packaging materials within own administrative region. During the review and approval of pharmaceutical preparation applications, the CFDA will organize onsite checking and inspection of the involved APIs, pharmaceutical excipients and pharmaceutical packaging materials, as needed.
Information change:
Enterprises of APIs, pharmaceutical excipients and pharmaceutical packaging materials that have obtained registration numbers shall conduct management in strict accordance with relevant requirements of the state, guarantee the product quality, and submit product quality management report by year after obtaining the registration numbers; they shall timely change relevant information on the registration platform in the event of changes of products, and shall proactively inform the pharmaceutical preparation applicants who use their products before implementing the changes. Pharmaceutical preparation applicants shall be responsible for the quality of the APIs, pharmaceutical excipients and pharmaceutical packaging materials selected, fully research and assess the impacts of changes of APIs, pharmaceutical excipients and pharmaceutical packaging materials on their products, conduct research according to relevant provisions and guiding principles of the CFDA, and file change applications or conduct filing as required.
This announcement generally explains the API DMF system which is the Drug Master File system to be established by the manufacturing enterprises themselves, and manufacturing enterprises shall provide relevant information to the preparation enterprises.
Next, let’s talk about the differences between API approval number system and DMF system.
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Item
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Approval number system
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DMF system
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Perspective of approval
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Separate the approval of APIs (including excipients and packaging materials) and approval of preparations, with the former independent of preparations
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Integrate approval of APIs (including excipients and packaging materials) and approval of preparations, with the filing materials to be submitted to the drug administration. Those undergoing filing only obtain filing numbers, and the specific technical review will be started together with the start of preparation registration
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Information change
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Manufacturing enterprises of APIs (including excipients and packaging materials) have independent approval numbers, shall proactively submit the change information to the drug administration in advance, and may implement the changes upon approval. The approval numbers are valid for 5 years, and re-registration applications shall be filed with the drug administration before expiration of the validity term, to obtain another 5-year validity term
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Manufacturing enterprises of APIs (including excipients and packaging materials) shall file the change information with the drug administration at any time on the premise of no purchasing from preparation users, at least reflecting it through the annual report (namely, the abovementioned annual product quality management report); on the premise of no purchasing from preparation users, manufacturing enterprises of APIs (including excipients and packaging materials) shall not only file the change information with the drug administration at any time, and more importantly, they shall timely notify preparation users of the change content, to have the latter access the impacts of such changes on related preparations. DMF number will be valid forever on the premise of completion of the above normal maintenance
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Liability subjects
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APIs (including excipients and packaging materials) are directly regulated by the drug administration, and preparation enterprises normally just need to make sure of the approval numbers to conduct purchasing, without responsibility for the specific production process of suppliers
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Preparation enterprises are responsible for the quality of the final products, and directly regulated by the drug administration, while manufacturing enterprises of APIs (including excipients and packaging materials) are indirectly regulated by the drug administration as supplier of preparation manufacturing enterprises
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ALL
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