CAJ | 학술논문

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。
국무원점명요구정개“약품심평심비”，위차 CFDA 근기출태다항유관정책。출태적계렬정책여조시반영출약품심비개혁량대목표：일방면통과중시약품질량고려창신，령일방면제승방제약수평，피면저수평중복。차거야가이인위시아국대우약품심평제도개혁적일개분수령。본문제료대상관정책진행해독외，환취기업여하면대신정제출일사간법，공기업삼고。
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.