On March 2020, the Chinese health authority NMPA increased considerably the registration fee of DMFs for APIs and added new registration requirements.

New Fees for API Manufacturers

Going forward, API manufacturers have to pay a fee of $50,000 to get their DMF’s registered in China. Additionally, they have to submit the following:

  • API specifications, analytical procedures and description of manufacturing process in Chinese and in English. Documents should be provided in hard copy and in electronic copy.
  • Samples from three batches that have been marketed abroad or domestically with corresponding certificates of analysis.  the quantity of samples from each batch should cover three full testing.
  • Reference standards with corresponding CoA.

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About Global Regulatory Partners:

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.

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