The Center for Drug Evaluation (CDE) has released the 76th batch of chemical generic reference preparations, which includes 11 new specifications, 16 additional specifications, and updates to 22 previously published specifications. The updates encompass the addition of domestic generic names and Marketing Authorization Holder (MAH) information.
Specifications Fail Review for Various Reasons
Eighteen specifications did not pass the review process due to the absence of reference preparation status and non-compliance with clinical practices in China and other factors.- Flcube.com
