Critical review on the Environmental Risk Assessment of medicinal products for human use in the centralised procedure

被引：11

作者：

Caneva, Laura ^{[1
]}

Bonelli, Milton ^{[1
]}

Papaluca-Amati, Marisa ^{[1
]}

Vidal, Jean-Marc ^{[1
]}

机构：

[1] European Med Agcy, Specialised Sci Disciplines Dept, London E14 4HB, England

来源：

REGULATORY TOXICOLOGY AND PHARMACOLOGY | 2014年 / 68卷 / 03期

关键词：

ERA; Risk assessment; EPAR; European Medicines Agency; Marketing authorisation;

D O I：

10.1016/j.yrtph.2014.01.002

中图分类号：

DF [法律]; D9 [法律]; R [医药、卫生];

学科分类号：

0301 ; 10 ;

摘要：

In this article we analyse the Environmental Risk Assessment (ERA) of 59 medicinal products for human use authorised in the EU through the centralised procedure between 2011 and 2012, to establish whether company submissions are compliant with the European Medicines Agency (EMA) guideline and complete in terms of data and study reports provided. The most frequent questions raised by EU regulatory authorities are described, together with an evaluation of the presence and quality of ERA-related information in published regulatory assessment documents. The results of this review show recent improvement in ERA-related data presented in regulatory assessment documents available to the public while also highlighting a need to develop further guidance on environmental issues in order to assist applicants improve their ERA dossiers and overcome current shortcomings. (C) 2014 Elsevier Inc. All rights reserved.

引用

页码：312 / 316

页数：5