In order to strengthen the supervision and management of APIs and to clarify the production and supply of APIs, the NMPA announced (No.96-2021) the development of an API production and supply information collection module in the drug information collection platform on November 3, 2021.
In an effort to steadily promote the use of this new module and to implement this new management work step by step, starting from the third quarter of 2021, the production and supply information of APIs for all drugs which have been included in the “National Scarce Drug List” and “National Key Monitoring List for Clinically Essential and Scarce drugs” must be collected through this new module. Depending on the needs of drug regulatory work, the NMPA will subsequently expand the scope of the information collection and include other API varieties into this project. At this stage, manufacturers of other API varieties can also voluntarily take part in this project.
Domestic API manufacturers should provide the production and supply information through this API production and supply information collection module and submit it online to the provincial drug supervision and management department.
If the manufacturer is an overseas enterprise, it should appoint a legal agent in China to submit the required information online to the local department of the province where the legal agent is located. The manufacturer and legal agent are responsible for the accuracy, comprehensiveness and completeness of the information provided. The collected API production and supply information can be used by drug regulatory authorities for inquiries.
The relevant API manufacturers should submit the API production and supply information by the end of November 2021. After that, they should do this before the 20th of the first month of each quarter for the previous quarter.
By Sun Jinlin. Contact Cisema if you would like to learn more.