欧盟药品注册也可以申请加速吗？

julia朱玉姣

在各国家，药品上市注册都有快速通道，那么欧盟是否也可以呢？是的。在EMA公布的问答中回答了该问题

8. Is my product eligible for an Accelerated Assessment Rev. Feb 10

8. 我的产品是否够格进行加速评审？

8.1. Legal basis and general principles 法规依据和一般原则

According to Articles 6(3) and 7c of Regulation (EC) No 726/2004, the maximum timeframe for the evaluation of a marketing authorisation application under the Centralised Procedure is 210 days, excluding clock stops when additional written or oral information is to be provided by the applicant in response to questions asked by the CHMP.

根据法规（EC）第726/2004号令7c条和6(3)条，一份上市许可申报在中央评审程序下最长评审时长为210天，不包括要求申报人提交额外书面或口头信息时停止计时的情况。

However, according to Recital 33 and Article 14(9) of Regulation (EC) No 726/2004, the applicant may request an accelerated assessment procedure in order to meet, in particular the legitimate expectations of patients and to take account of the increasingly rapid progress of science and therapies, for medicinal products of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation.

但是，根据法规（EC）第726/2004号令33条和14（9）条，申报人可以要求加速评审程序，以符合，特别是，患者的合法期望和科学和治疗的快速进步，从公众健康出发重要利益的药品，特别是从治疗创新观点出发。

Applicants requesting an accelerated assessment procedure should justify that the medicinal product is expected to be of major public health interest. Based on the request, the justifications presented, and the recommendations of the Rapporteurs, the CHMP will formulate a decision. Such a decision will be taken without prejudice to the CHMP opinion (positive or negative) on the granting of a marketing authorisation.

申请人申请加速评审程序应论证重要公众健康利益需求该药品。基于所呈交的论证，以及报告起草人的推荐，CHMP将做出决定。该决定不会受到CHMP关于是否认可上市许可的态度影响。

If the CHMP accepts the request, the timeframe for the evaluation will be reduced to 150 days.

如果CHMP接受申请，则评估时间会减少为150天。

一沙一叶

重要公众健康利益

曹小芬爱疯叮

150天，办事效率就是高。。