On November 14, China’s NMPA announced the document titled “Interim Provisions on the Administration of the Designation of Domestic Responsible Persons by Overseas Drug Marketing Authorization Holders.” These provisions outline the requirements for domestic responsible persons. Imported pharmaceuticals’ quality and safety are secured by the DRP system. The China DRP system includes the following conditions – 1. It must be a legal enterprise in China; 2. It must maintain a QMS system; 3. It must include the appropriate people and organizational structure to maintain quality management, and 4. Have an office in China to facilitate DRP activities.
Both the overseas MAH and the DRP are responsible for the quality and safety of imported drugs. They are both liable for imported drugs. Both entities are also responsible for reporting things such as sales, post-market activities, submitting annual reports, etc. – to the local provincial health authorities. These provisions will be put in place on July 1, 2025. Thus, foreign drug makers selling drugs in China must make efforts now that their DRP will meet these qualifications, redo instruction documents to contain DRP information and issue other appropriate documents to meet DRP requirements.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.