仿制药一致性评价工作的进展与展望
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摘要
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.
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.
引文
[1]国家食品药品监督管理总局.关于发布仿制药质量和疗效一致性评价品种分类指导意见的通告(2017年第49号)[EB/OL].(2017-04-05)[2018-05-07].http://samr.cfda.gov.cn/WS01/CL0087/171385.html
[2]国家食品药品监督管理总局.关于2018年底前须仿制药质量和疗效完成一致性评价品种批准文号信息[EB/OL].(2016-08-17)[2018-05-07].http://samr.cfda.gov.cn/WS01/CL1 757/163161.html
[3]国家食品药品监督管理总局.关于企业开展289目录内仿制药质量和疗效一致性评价基本情况信息[EB/OL].(2017-08-21[2018-05-07].http://samr.cfda.gov.cn/WS01/CL1 757/176275.html
[4]国家食品药品监督管理总局药品审评中心.关于更新《289目录品种参比制剂基本情况表》的通知[EB/OL].(2018-02-14)[2018-05-07].http://www.cde.org.cn/news.do?method=large Info&id=314366.
[5]TAO L B.Drug shortage:experiences and implications form developed countries[J].Chin J Health Policy(中国卫生政策研究),2008,1(3):38-42.
[6]焦莎莎,贾利利.浅析低价药供应不足的现状及应对策略[J].科技展望,2016(14):291.
[2]国家食品药品监督管理总局.关于2018年底前须仿制药质量和疗效完成一致性评价品种批准文号信息[EB/OL].(2016-08-17)[2018-05-07].http://samr.cfda.gov.cn/WS01/CL1 757/163161.html
[3]国家食品药品监督管理总局.关于企业开展289目录内仿制药质量和疗效一致性评价基本情况信息[EB/OL].(2017-08-21[2018-05-07].http://samr.cfda.gov.cn/WS01/CL1 757/176275.html
[4]国家食品药品监督管理总局药品审评中心.关于更新《289目录品种参比制剂基本情况表》的通知[EB/OL].(2018-02-14)[2018-05-07].http://www.cde.org.cn/news.do?method=large Info&id=314366.
[5]TAO L B.Drug shortage:experiences and implications form developed countries[J].Chin J Health Policy(中国卫生政策研究),2008,1(3):38-42.
[6]焦莎莎,贾利利.浅析低价药供应不足的现状及应对策略[J].科技展望,2016(14):291.