NMPA Releases 92nd Batch of Reference Drugs for Generic Quality Evaluation

NMPA Releases 92nd Batch of Reference Drugs for Generic Quality Evaluation

The National Medical Products Administration (NMPA) has released the 92nd batch of reference drugs for the generic quality consistency evaluation (GQCE) work. This batch encompasses a total of 47 specifications, including 33 new specifications and 14 modified ones.

Details of the Release
The latest release by the NMPA is part of the ongoing efforts to ensure the quality consistency of generic drugs in China. The inclusion of 33 new specifications and modifications to 14 existing ones reflects the administration’s commitment to expanding and updating the reference drug list to meet clinical needs and regulatory standards.

Significance for Generic Drug Manufacturers
This update provides guidance for generic drug manufacturers aiming to align their products with the quality standards set by the reference drugs. It also underscores the dynamic nature of the drug evaluation process, where continuous updates are necessary to incorporate new scientific data and clinical requirements.-Fineline Info & Tech