The National Medical Products Administration (NMPA) has released the 87th batch of reference drugs for generic quality consistency evaluation (GQCE) work, furthering its efforts to ensure the quality and consistency of generic medications in the market.
Expansion of Reference Drug Specifications
This latest batch encompasses 38 new specifications for reference drugs, marking a significant expansion in the range of medications under evaluation. In addition to these new entries, the batch also includes 21 specifications that have undergone modifications. These modifications are primarily focused on changing or adding Marketing Authorization Holders (MAHs), reflecting the dynamic nature of the pharmaceutical industry and the need for continuous updates to regulatory frameworks.
Enhancing Generic Drug Quality and Safety
The release of the 87th batch of reference drugs is a step towards maintaining high standards for generic drugs. By providing a clear set of reference specifications, the NMPA aims to facilitate the evaluation of generic drugs against their branded counterparts, ensuring that they meet the same stringent quality and efficacy standards.-Fineline Info & Tech
