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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.
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.
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.
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.