The Center for Drug Evaluation (CDE), a key regulatory body overseeing pharmaceutical evaluations in China, has issued a call for feedback on the 80th batch of chemical generic reference preparations. The public consultation period is set to conclude on March 29, 2024. This initiative is part of the CDE’s ongoing efforts to standardize and enhance the quality of generic drugs within the Chinese market.
Among the submissions under review, there are 10 drug specifications that have not yet been introduced in China, along with 46 additional specifications that have been added to the list. However, the evaluation process has proven challenging for some, with a total of 6 specifications failing to meet the CDE’s stringent criteria. The reasons for the failure include the absence of reference preparation status, non-compliant dosage forms, and/or an insufficient data set to support their approval.
This review cycle underscores the CDE’s commitment to ensuring that only the highest standards of safety, efficacy, and quality are met by generic drug manufacturers looking to enter or expand within the Chinese pharmaceutical market.- Flcube.com
