On Dec 8, 2020, National Medical Products Administration (NMPA) issued the draft Provisions on the Administration of the Drug Annual Report and the draft Templates for the Drug Annual Report for consultation, openly circulating for comments from the public until Dec 22, 2020.
According to the consultation for Provisions on the Administration of the Drug Annual Report, the Marketing Authorization Holder (MAH) shall collect and summarize the drug related information of the last calendar year, and report those information through the annual report system by March 31st each year. The annual report should include information on the production, sales, post-marketing study, and risk management of the finished products, etc. If MAH is an overseas enterprise, the obligation of annual reporting shall be fulfilled by its designated legal person in mainland China.