Mutual recognition in the European system: A blueprint for increasing access to medicines?

被引：5

作者：

Skrnjug, Ivana ^{[1
]}

Uzeirbegovic, Sabina ^{[2
]}

Romcevic, Maja Lovrek ^{[2
]}

Tomic, Sinisa ^{[2
]}

Meyer, Heidi ^{[1
]}

Conrad, Christoph ^{[1
]}

机构：

[1] Paul Ehrlich Inst, Paul Ehrlich Str 51-59, D-63225 Langen, Germany

[2] Agcy Med Prod & Med Devices Croatia, Ksaverska Cesta 4, Zagreb 10000, Croatia

来源：

REGULATORY TOXICOLOGY AND PHARMACOLOGY | 2019年 / 106卷

关键词：

Mutual recognition; Work-sharing; Reliance; Regulatory harmonisation; Access to medicines; REGULATORY NETWORK; MARKET ACCESS; PHARMACEUTICALS;

D O I：

10.1016/j.yrtph.2019.05.004

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：

The European regulatory system for approval of medicinal products is globally recognised as a unique platform for regulatory work-sharing and mutual recognition. As such, it potentially serves as a role model for regulatory capacity building worldwide. While focusing on mutual recognition and decentralised procedures, this paper illustrates key success factors and structures allowing for the reliance-based authorisation of medicines in the European Economic Area from the perspective of a national regulatory authority (NRA). This paper presents major challenges in fulfilling the requirements for joining the European Medicines Regulatory Network (EMRN) and the strategies regarding how those challenges could be successfully addressed based on the example of the Agency for Medicinal Products and Medical Devices of Croatia, the most recent NRA in the EMRN. It also discusses the hallmarks of successful implementation of the European system of reliance as a blueprint for increasing access to safe and efficacious medicines from the perspective of a NRA.

引用

页码：270 / 277

页数：8