The Center for Drug Evaluation (CDE) has released the 72nd batch of chemical generic reference preparations, which includes 19 new specifications. Among these, 2 are injectable formulations. Additionally, information for 19 previously published specifications has been updated, with updates also involving 2 injectable drugs. The CDE is seeking public feedback on this document, which will remain open until July 17, 2023.
Specifications Review and Updates
The latest batch of reference preparations is part of the CDE’s ongoing efforts to standardize and improve the evaluation process for generic chemical drugs. The inclusion of new specifications and updates to existing ones aims to enhance the consistency and quality of pharmaceuticals in the market. The public is encouraged to provide feedback to ensure that the reference preparations meet the necessary standards and requirements.
Specifications That Failed Review
In this batch, seven specifications did not pass the review process. The reasons for failure include insufficient data and the lack of reference preparation status, among others. This highlights the importance of stringent review processes to ensure that only the highest quality and properly documented reference preparations are included in the CDE’s list.-Fineline Info & Tech
