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国办:将仿制药质量和疗效一致性评价逐步向滴眼剂、贴剂、喷雾剂等剂型拓展

The State Council Office will gradually expand the consistency evaluation of quality and efficacy of generic drugs to formulations such as eye drops, patches, and sprays.

Breakings ·  Jan 3 17:12

Recently, the General Office of the State Council issued the "Opinions on Comprehensively Deepening the Supervision and Reform of Pharmaceuticals and Medical Instruments to Promote High-Quality Development of the Pharmaceutical Industry." It promotes the improvement of the quality of generic drugs. It optimizes the review and verification mechanisms for generic drugs, increasing the intensity of dynamic inspections before approval based on product risks. It strengthens the supervision of entrusted research and development, entrusted production, and post-market changes, supporting enterprises with high levels of information technology, strong quality assurance, and risk control capabilities to accept commissions. The consistency evaluation of quality and efficacy of generic drugs will gradually expand to formulations such as eye drops, patches, and sprays.

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