Registration of Drug Master File (DMF) of APIs in China

The registration process of the Drug Master Files (DMFs) for Active Pharmaceutical Ingredients (APIs) has undergone substantial reforms, since China joined the ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) in 2017. Foreign API manufacturers, without local presence in China, should appoint a local representative in China that can register their DMF with NMPA on their behalf. 

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 South Korea GRP helps many life science companies register their products in different countries in compliance with local regulations.