China: Drug Annual Reporting for MAH Holders

On April 11, the NMPA issued a new Circular on year-end drug annual reporting. China MAH’s must submit 2021 annual reports by August 2022. However, after this year, annual reports must be submitted by the end of April each year. The circular also provides information on documents that need to be submitted as part of the annual report. Besides general information on the product, risk management information, etc., many other specific provisions were outlined. Some of these include updates on the number of drugs imported into China, international and China sales of similar types of drugs, updates on domestic manufacturing, etc. The circular also says that government officials have the right to inspect the MAH’s records of inspection and annual reporting system. If an MAH does not follow these rules closely, provincial drug authorities can issue appropriate fines.