有关药品再注册工作的思考与建议

On Drug Re-registration Application

药品再注册工作是药品监督管理部门对上市产品安全有效、质量可控性的延续性审查,用以通过系统评价去淘汰不具备生产条件、质量不能保证、安全风险较大的品种。目前,通过两轮大规模的再注册工作实践,虽然对产品上市后的情况进行了一定的梳理与规范,但这项工作存在的问题与矛盾也日益凸现。本文期望通过总结经验教训,借鉴美国和欧盟药品上市后的监管模式,提高我国对上市产品的风险把控监管能力。

Drug re-registration application is the continuous review on the safety efficacy and quality control of marketed-products. It aims at ensuring the safety of drug use by systematical review to kick out the products which can not be manufactured, or have high safety risk, or whose quality can not be guaranteed. At present, two rounds of large-scale re-registration have been conducted, although it did comb and standardize the marketed products to some extent, the problems and contradictions have also been gradually highlighted. By excavating the problems and mirroring the experiences of FDA and EMA, the control and regulatory abilities of the risk of marketed products could be enhanced.