In order to better serve the applicants and further improve the quality and efficiency of the selection of reference drug, CDE has developed “The requirements for application documents for selection of reference drug of generic chemical drugs (see Annex)”. According to the release procedure of Technical guidelines noticed by General Department of the NMPA ( [2020] No.9), CDE published "the requirements for application documents for the selection of reference drug of generic chemical drugs" and go into effect from the date of promulgation.
NMDA Center of Drug Evaluation
16th Oct, 2020
Appendix 1. The requirements for application documents for selection of reference drug of generic chemical drugs.
