China’s National Medical Products Administration (NMPA) has released the 64th batch of reference drugs for generic quality consistency evaluation (GQCE) work. The latest release includes 53 new specifications, involving nine injectables and 10 specifications with modifications.
Details of the Release
The new batch of reference drugs is part of the ongoing efforts to ensure the quality and consistency of generic drugs in the Chinese market. The 53 new specifications include a variety of formulations, with a particular focus on injectable products. Additionally, the NMPA has introduced modifications to some specifications, including the addition of marketing authorization holders (MAH) and the removal of limitations on trade names.
Implications for the Industry
The release of the 64th batch of reference drugs underscores the NMPA’s commitment to enhancing the quality and safety of generic drugs. By providing clear guidelines and reference standards, the GQCE program aims to support the development of high-quality generics, promote competition, and ultimately benefit patients through more accessible and reliable treatment options.-Fineline Info & Tech
