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.

Need help understanding more about the China's CDE? GRP has the Answers ! contact us !


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