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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and efficacy of generic drugs for injections, National Medical Products Administration of China（NMPA）published the draft guidance “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.