药品审评正本清源方能保证药品的质量与疗效

The reformation of drug evaluation from the bottom can ensure the quality and effectiveness of drugs

国务院点名要求整改"药品审评审批",为此CFDA近期出台多项有关政策。出台的系列政策与措施反映出药品审批改革两大目标:一方面通过重视药品质量鼓励创新,另一方面提升仿制药水平,避免低水平重复。此举也可以认为是我国对于药品审评制度改革的一个分水岭。本文除了对相关政策进行解读外,还就企业如何面对新政提出一些看法,供企业参考。

The State Council singled out the rectification and reformation of drug evaluation. As a result, CFDA has recently introduced a number of relative policies. These policies have reflected two main objectives of the reformation of drug evaluation： the first is to encourage innovation by attaching importance to drug quality, and the second is to improve the productive levels of generics to avoid low-level duplication. The move of the State Council would be regarded as a watershed in the reformation of drug evaluation system. Some personal suggestions on how to face the new policies will be proposed besides expounding the relative policy so as to provide a reference for pharmaceutical companies.