The National Medical Products Administration (NMPA) has released the 84th batch of reference drugs for generic quality consistency evaluation (GQCE) work, marking a significant step in the regulation of generic drug quality in China. Concurrently, the NMPA has also announced the first batch of reference drugs that have been stripped of their status.
New Inclusions and Modifications in the Reference Drug List
This latest batch includes 53 new specifications for the first time, along with 37 modified specifications. These updates are crucial for maintaining the standards of generic drugs and ensuring their consistency with the original branded medications.
Removal of Ambroxol Inhalation Solution from the Reference List
Notably, Ambroxol inhalation solution, originally developed by French pharmaceutical giant Sanofi (NASDAQ: SNY), has been removed from the reference list. The removal is attributed to the solution’s non-compliance with the General Principles for Inhalation Preparations in the Chinese Pharmacopoeia. Specifically, the pharmacopoeia requires that ‘inhaled liquid preparations should be sterile,’ a criterion that the solution failed to meet.- Flcube.com
