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On July 22, 2021, the CDE official website of the State Drug Administration issued the "Notice on the timely submission of annual reports on APIs, pharmaceutical excipients and pharmaceutical packaging materials".
1.
1.
(1) On November 23, 2017, the State Administration issued the "Announcement on Adjusting the Review and Approval of APIs, Pharmaceutical Excipients and Pharmaceutical Packaging Materials (2017 No.
(2) On July 19, 2019, the State Food and Drug Administration issued the "Announcement on Further Improving the Related Matters of Drug-related Review, Approval, and Supervision" (No.
(3) The "Administrative Measures for Post-Marketing Changes of Drugs (Trial)" (No.
2.
2.
(1) After obtaining the registration number, submit a product quality management report on an annual basis; when the product changes, relevant information should be changed in the registration platform in a timely manner
(2) The registrant of the original auxiliary package should submit the previous year’s annual report through the applicant’s window in the first quarter of each year; the annual report should include a summary of product changes in the previous year, and if there is no change, there should be a relevant statement; in the annual report product information should be relevant, such as business name, drug name and so on
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