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Notice on timely submission of annual reports on APIs, pharmaceutical excipients and pharmaceutical packaging materials
Release time:
2021-07-26 14:59
According to Article 15 of the Announcement of the State Food and Drug Administration on Further Improving the Relevant Matters of Drug Related Review, Approval and Supervision (No. 56 of 2019), "If there is a technical change in the API labeled 'A', an application for change shall be submitted in accordance with the relevant provisions of the current drug registration administration, which shall be implemented after approval. Other changes of API, pharmaceutical excipients and packaging materials shall be updated in the registration platform in a timely manner and summarized in the annual report of the previous year submitted in the first quarter of each year."
Considering that some API, pharmaceutical excipients and pharmaceutical packaging materials manufacturers did not submit annual reports on time due to the epidemic, in order to encourage enterprises to resume work and production, after consulting the National Bureau, now open API, pharmaceutical excipients and pharmaceutical packaging materials annual report submission time. The resumption of the annual report submission time limit will be notified separately.
Notice is hereby given.
Center for Drug Evaluation, State Drug Administration
July 22, 2021
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