The Center for Drug Evaluation (CDE) has released the 70th batch of chemical generic reference preparations, marking a significant update in the generic drug sector. This batch includes 18 new specifications and updates to 23 previously published specifications. The document is open for public feedback until June 15, 2023, ensuring transparency and stakeholder engagement in the drug evaluation process.
Specifications Review and Updates
The release of the 70th batch of generic reference preparations is part of CDE’s ongoing efforts to standardize and improve the quality of generic drugs. The update includes new specifications that aim to align with international standards and best practices. Additionally, 23 existing specifications have been revised to reflect the latest scientific advancements and regulatory requirements.
Specifications That Failed Review
Eleven specifications failed the review process due to various reasons, including the lack of reference preparation status, discrepancies with international expert consensus, or failure in re-examination. This stringent review process underscores CDE’s commitment to maintaining high standards for drug quality and safety.
Public Feedback and Its Importance
The public feedback period is crucial for the refinement of these reference preparations. It allows stakeholders, including pharmaceutical companies, healthcare professionals, and patients, to contribute their insights and ensure that the final specifications meet the needs of the industry and the public. The feedback received will be instrumental in shaping the final guidelines for the 70th batch of generic reference preparations.-Fineline Info & Tech
