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In mid 2019, NMPA implemented a new process for pharmaceutical excipients registration in China, manufacturers have to register the DMF of their excipients using the CDE platform that generates automatically the DMF number.
Manufacturers of pharmaceutical excipients (excipients) should file their DMFs with required technical information to NMPA directly. Overseas manufacturers, with no presence in China, should authorize their domestic subsidiary or an agent to file their DMFs.Both manufacturers and their agents are responsible for the authenticity and integrity of the filed DMFs.
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.