In China, a Reference Listed Drug (RLD) is defined as the first drug approved for marketing in China and/or abroad and that is supported by complete and sufficient safety and effectiveness clinical data. Selecting the appropriate (RLD) is mandatory before submitting the application for the registration of a generic drug (ANDA) in China. Information on the RLD should be included in the ANDA, otherwise it is not accepted by NMPA.

About Global Regulatory Partners Group

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.