MFDS Issues Guide on GMP Certification for Biopharmaceutical Raw Materials

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Biopharmaceutical Raw Material Manufacturing Facility
Biopharmaceutical Raw Material Manufacturing Facility

The Ministry of Food and Drug Safety (MFDS) published the “Guide on Submission Requirements for GMP Certification of Biopharmaceutical Raw Material Manufacturing Sites” on October 8 to support the research and development of domestic biopharmaceutical raw materials. This guide includes the targets of GMP certification, applicable standards, submission requirements, evaluation methods, and procedures.


The MFDS expects this certification system to enhance the quality and reliability of domestic biopharmaceutical raw materials and contribute to their localization. The agency plans to select target companies for the GMP certification program by November. It will continue to actively support the research, development, and commercialization of biopharmaceutical raw materials.


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