Drug Master File Series


Since July 2019, NMPA requires manufacturers of Pharmaceutical Packaging Materials (PPM) to register the DMF of their products using CDE platform and obtain a DMF number. Foreign manufacturers with no presence in China, should appoint local agents who can prepare and submit their DMF to CDE on their behalf.

Need to register your dmf in china?

GRP DMF Expertise in china:

Case Study 118: Registration of API in China

Client is a multinational company, leader in the production and supply of APIs for radiopharmaceuticals and radioisotopes. The company received many requests from Chinese pharmaceutical companies, who were interested in buying one of its APIs and use it in their drug product’s formulation.

Case Study 8: Registration of DMF for Packaging Materials in China

Client was looking for a partner in china that can register a DMF of their packaging material, the transdermal delivery system used for drugs presented in dermal patches in China.

About Global Regulatory Partners Inc:

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.