China’s National Medical Products Administration (NMPA) has released the 94th batch of reference drugs for the Generic Quality Consistency Evaluation (GQCE) work. This update includes 42 new specifications and 18 modified specifications. Additionally, 6 drug specifications have been removed from the list.
Details of Changes
In this release, the NMPA introduced 42 new specifications to the reference drugs list for the first time. Additionally, 18 specifications underwent modifications to align with the latest standards and guidelines. These changes aim to ensure that generic drugs meet the highest quality and efficacy standards.
Removed Specifications
Six drug specifications were removed from the reference drugs list. The primary reasons for removal were unsuitable dosage forms of the current reference drugs or non-compliance with Chinese Pharmacopoeia regulations. This ensures that only the most appropriate and compliant drugs serve as references for generic quality consistency evaluations.-Fineline Info & Tech
