仿制药一致性评价工作的进展与展望

Progress and Prospect of Generic Drug Consistency Evaluation

目的研究分析当前仿制药质量和疗效一致性评价的现状及存在问题,提出推进仿制药一致性评价的建议。方法梳理并分析我国基本药物化学药品目录中口服固体制剂的品种情况、持有文号的生产企业情况、参比制剂公布情况及实施仿制药一致性评价中的问题。结果低价药、独家品种开展一致性评价比例偏低,未来可及性风险不容忽视。结论生产企业要落实评价主体责任,以提高质量作为企业发展要务;相关管理部门应加快出台激励政策,助推企业开展仿制药一致性评价。

OBJECTIVE To investigate the current status and existing problems in quality and efficacy consistency evaluation of generic drugs, and to propose suggestions for facilitating generic drug consistency evaluation. METHODS The product varieties, approval numbers held in manufacturers, publicity of reference products, as well as the problems identified in implementing generic drug consistency evaluation were summarized and analyzed for the oral solid dosage forms of the chemical generic drugs included in the National Essential Medicines List. RESULTS The proportions of low-price and exclusive products involved in consistency evaluation remain relatively low, implicating that future accessibility risk was not negligible. CONCLUSION The manufacturers are expected to assume their responsibilities in consistency evaluation and focus on quality improvement in their development;the competent regulatory authorities are expected to accelerate the issuance of incentive policies and measures, so as to facilitate generic drug consistency evaluation for the manufacturers.