China’s NMPA announced on March 25, 2022, the issue of the 57th batch of RLD (Reference Listed Drug) for public industry comments.
RDL Batch Timelines with China’s CDE
Currently CDE has implemented final RLD till No.52 batch. It normally takes about 1.5-2 months from draft RLD disclosure to final RLD implementation.
The “Call for Public Industry Comments” will last about 10 working days from March 25th to April 8th . As per the latest drug registration acceptance guideline, the final RLD confirmation is required for ANDA filing in China.
Catalog of Reference Preparations of Generic Chemical Medicines (57th batch)
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, pharmaceutical, cosmetic and Food Supplement 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.