The Center for Drug Evaluation (CDE), China’s regulatory body, is currently seeking public feedback on the 82nd batch of chemical generic reference preparations, with the consultation period scheduled to close on May 16, 2024.
The list under review encompasses nine new specifications that are being considered for the first time, in addition to 28 existing specifications that have been added. However, the review process has not been favorable for all, with 29 specifications failing the assessment. The reasons for the failure include the absence of reference preparation status and/or inadequate data, among other concerns.- Flcube.com
