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
Items | Details |
MAH basic information | The MAH's name, drug production license number, the unified social credit code and production location(s). |
Product information | Name, approval number, specification, production status, etc. |
Production and sales | Domestic and overseas sales of all specifications of the same variety. |
Post-marketing studies | Research items if the conditional marketing authorization or generic drug consistency evaluation is applicable, and all post-approval changes that are supposed to be reported under NMPA's requirement, etc. |
Risk management | Including investigating and handling unqualified products, product recall, and risk control in the sales of commercial-scale batches that have passed the inspection for verifying the drug's compliance with GMP standards before marketing approval, etc. |
Others | Details like drug name, dosage form, specification, third party manufacturer's name and country for product processing that is entrusted abroad. |
The required annual report intends to put stringent supervision on drug enterprises to proactively disclose relevant information, and further ensure drug safety management. A template of the annual report in Chinese can be downloaded here. BaiPharm can help with the preparation of annual report for global drug companies.
