China Requires Drug Market Authorization Holders to Submit Annual Report

Drug Market Authorization Holders are required to submit relevant drugs' annual reports every year in China. An annual report should cover production and sales, post-marketing studies, and risk management of drugs.
by Grace Wang Mar 08, 2021

On Dec. 10, 2020, the National Medical Products Administration (NMPA) published the drafts of Administrative Provisions of Annual Drug Reports and Template for the Annual Drug Report, asking for public consultation before Dec. 22, 2020.1

According to the provisions, the Market Authorization Holders (MAHs) should manage their annual report system and submit relevant drugs' annual reports of the previous calendar year to local administrators before Mar. 31 of each year. Applicants are allowed to correct their submitted information only before Mar. 31. The MAH should bear corresponding liability if any non-compliance is found. If the MAH is an overseas company, its legal person in China shall fulfill the obligation.

Main Content of the Annual Report

Grace Wang
ChemLinked Regulatory Analyst
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