Please select a region
Manage Consent Preferences
Strictly Functional Cookie
Our site is undergoing a scheduled maintenance from 30th December 2020 to 3rd January 2021 and some functionalities will not be available at this time
June 26, 2020
To improve the consistent evaluation of the quality and efficacy of generic drugs for injections, National Medical Products Administration of China（NMPA）published the draft guidance “<em>Technical Requirement for Quality and Efficacy Consistency Evaluation on Chemical Generic Injections (Exposure Draft)</em>” (15 October 2019). This indicates that the evaluation of the consistency of injections has finally begun. This Exposure Draft clarifies the specific technical requirements on reference-listed drugs, prescription technology, quality control of bulk drugs and excipient packaging, quality studies and control, stability studies, etc.