"Regulations on the Administration of Drug Annual Reports" will come into effect on April 12

In order to standardize the management of the annual reports of drug marketing authorization holders, the State Drug Administration issued a notice today to officially release the "Regulations on the Administration of Drug Annual Reports" (hereinafter referred to as the "Administrative Regulations")

The purpose of implementing the drug annual report system is to supervise the implementation of the main responsibility for the whole-process quality management of drug marketing authorization holders

Division of labor and cooperation between drug regulatory departments

The "Administrative Regulations" make it clear that the State Drug Administration is responsible for guiding the management of the national drug annual report

The listing authorisation holder is responsible for the annual report

The "Administrative Regulations" emphasize that the holder of the drug marketing authorization is the main body responsible for the annual report, and is responsible for its authenticity and accuracy

Online filing + information sharing

The drug annual report collection module is divided into the enterprise side and the regulatory side

If the holder fails to submit the annual report as required, in accordance with the provisions of Article 127 of the Drug Administration Law, it shall be ordered to make corrections within a time limit and given a warning; if it fails to make corrections within the time limit, a fine of not less than 100,000 yuan but not more than 500,000 yuan shall be imposed.