The National Medical Products Administration (NMPA) has released the 68th batch of reference drugs for generic quality consistency evaluation (GQCE) work, marking a significant step in ensuring the quality and consistency of generic drugs. This batch includes 41 new specifications, highlighting the NMPA’s ongoing commitment to enhance the standards of generic medications, which involve 17 injectables and 24 specifications with modifications.
Details of the New Specifications and Modifications
The modifications featured in this batch encompass an expansion in the roles of marketing authorization holders (MAHs) and the removal of trade name restrictions. These changes are designed to streamline the process and encourage a more dynamic and competitive generic drug market, which ultimately benefits consumers by increasing access to high-quality, cost-effective medications.
Implications for the Generic Drug Market
The release of the 68th batch of reference drugs by the NMPA is a clear indication of the regulatory body’s proactive approach to improving the generic drug industry. By setting clear quality benchmarks and adjusting regulations to accommodate market dynamics, the NMPA is facilitating a more efficient and reliable generic drug supply chain.-Fineline Info & Tech
