The Center for Drug Evaluation (CDE) has issued a call for feedback on the 79th batch of chemical generic reference preparations, with the public consultation period set to end on March 5, 2024. This initiative is part of the CDE’s ongoing efforts to standardize and enhance the quality of generic drugs in the market.
The list under review features 40 new specifications and an additional 57 specifications, including 8 for injectable drugs. However, 26 specifications did not meet the review criteria and were not approved. The reasons for the failure to pass the review include the absence of reference preparation status, inconsistencies in packaging, a lack of clear clinical advantages, and/or insufficient data to support their approval.
This process underscores the CDE’s commitment to ensuring that only the highest standards of safety, efficacy, and quality are met by generic drug manufacturers, thereby protecting public health and promoting trust in the pharmaceutical industry.- Flcube.com
