China’s NMPA issues four technical guidelines for bioequivalence studies of specific varieties
China’s NMPA Announces Good Practice for Timing Termination and Restoration of Review in the Process of Drug Evaluation
China’s CDE- Guidelines for Summary of Adverse Drug Reaction Data in Labeling of Antineoplastic Drugs
China’s CDE issued on March 21st, 2022 the guidelines for the listing Adverse reaction in package inserts.
Overview: In order to better carry out the scientific supervision of risk-based clinical trials, according to the arrangements of the state bureau, our center CDE organized the drafting of the “technical guidelines for program change during drug clinical trials” and the drafting instructions. Introduction CDE has issued a draft technical guideline about protocol amendment during […]
On February 10, 2021, The CDE (Center for Drug Evaluation) of the NMPA in China has recently released “Guidelines for Acceptance and Review of Chemical Drug Changes”GRP Blog outlines how the NMPA reviews the application after receiving it and any necessary notes when preparing the application.
On February 10, 2021, The CDE (Center for Drug Evaluation) of the NMPA in China has recently released “Guidelines for Acceptance and Review of Chemical Drug Changes” with Information on requirements for completing a Chemical Drug Change.