The Center for Drug Evaluation (CDE) has announced the release of the 75th batch of chemical generic reference preparations. This update includes the addition of 14 new specifications and the expansion of 68 existing specifications. Additionally, 16 previously published specifications have seen their Marketing Authorization Holder (MAH) information updated.
Review Outcomes and Specification Changes
The CDE’s latest release reflects ongoing efforts to enhance the availability and quality of generic drugs in the market. The addition of new specifications and the updating of existing ones aim to provide clearer guidelines for manufacturers and ensure that the generics align with the latest standards in safety and efficacy.
Failed Reviews and Criteria
Conversely, 39 specifications did not pass the review due to various reasons, including insufficient safety and efficacy data, lack of reference preparation status, and the originators not being approved in key markets such as the US, Europe, or Japan. This rigorous review process underscores the CDE’s commitment to maintaining high standards for drug safety and performance.-Fineline Info & Tech
