The Center for Drug Evaluation (CDE) in China has released the 69th batch of chemical generic reference preparations, which includes 10 new specifications and updates to 31 previously published specifications. This release is a significant step in the ongoing effort to standardize and improve the quality of generic drugs available in the market.
Public Feedback Invited on Updated Generic Chemical Preparations
The document detailing these preparations is open for public feedback until May 16, 2023. This period allows stakeholders, including healthcare professionals, patients, and the general public, to review the new and updated specifications and provide their input. The CDE’s initiative to solicit public opinion is part of its commitment to ensuring that the generic drugs meet safety and efficacy standards.
Challenges Faced by 25 Specifications in Review
In the review process, 25 specifications did not pass the evaluation due to various reasons, including the lack of reference preparation status or presenting safety risks. This stringent review process is crucial for maintaining the integrity and reliability of the generic drug market.-Fineline Info & Tech
