China Drug Annual Reports Administrative Regulations was issued (No.16-2022) by the National Medical Products Administration (NMPA) on April 12, 2022.
Unsure how to file annual reports for your drugs marketed in China?
As a supporting document to the Drug Administration Law, this regulatory document sets out the management provisions of drug annual reports and the content template of annual report for drugs that have been approved for marketing in China. The NMPA also built a drug annual report collection information website. The market authorization holder (MAH) should establish and implement an annual reporting system for drugs from the year following the approval of the drug.
China Drug Annual Reports Administrative Regulations – Highlights
A summary of the new regulation specifying how to file your annual report for drugs marketed in China has been prepared by our regulatory experts below.
- The MAH shall establish an annual reporting system. For drugs that have been approved for marketing in the current year, MAH shall implement reporting system from the following year onwards.
- If the MAH is an overseas company, a legal agent(LA) in China should be designated to fulfill the annual reporting obligations.
- Annual report includes basic information and products information. For the latter, it mainly includes the production and sales, post-marketing research and risk management of drugs.
- The Information Center of NMPA has built a drug annual report collection module, which is still in the trial operation stage. The deadline for filling in the 2021 annual report information is August 31, 2022. Starting from next year, the MAH or LA should submit annual reports before April 30 each year.
- The drug regulatory department shall supervise and guide MAH to establish and implement the annual report, conduct a random inspection of annual report in combination with the supervision and inspection, and form an inspection report.
- If MAH fails to submit an annual report as required, he shall be given a warning in accordance with Article 117 of the Drug Administration Law and ordered to make corrections within 20 working days; if he fails to do so, he shall be fined not less than RMB 100,000 and not more than RMB 500,000.
- The annual report cannot replace the drug registration, production administrative license or the matters that need to be filed as stipulated in the drug laws and regulations.
By Yu and Jacky. If you would like to learn more about how to file your Drug Annual Report or our registration and CRO services for pharmaceuticals, medical devices, IVDs, cosmetics, health foods, industrial or consumer goods, please contact Cisema.