The Center for Drug Evaluation (CDE) has released the 71st batch of chemical generic reference preparations, marking a significant update in the generic drug sector. This batch includes 24 new specifications, of which 7 are injectables. Additionally, 33 previously published specifications have been updated, with information on 10 injectables being revised. The CDE’s document is open for public feedback until June 25, 2023, allowing stakeholders to contribute to the refinement of these standards.
Public Feedback Period and Specification Review
The CDE’s initiative to update and expand its reference preparations is part of its ongoing efforts to enhance the quality, safety, and efficacy of generic drugs in China. The public feedback period is an essential component of this process, ensuring that the final specifications meet the needs of the pharmaceutical industry and patients. The review of specifications is a rigorous process, with twenty specifications failing the review due to the lack of reference preparation status, highlighting the CDE’s commitment to maintaining high standards.
The Importance of Reference Preparations in Generic Drug Development
Reference preparations play a crucial role in the development of generic drugs, providing a benchmark for quality and efficacy. The expansion and updating of these specifications by the CDE are steps towards ensuring that generic drugs in China are consistent with international standards and can effectively substitute for their branded counterparts.-Fineline Info & Tech
