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

Autori
Škrnjug, Ivana ; Uzeirbegović, Sabina ; Romčević, Maja Lovrek ; Tomić, Siniša ; Meyer, Heidi ; Conrad, Christoph

Izvornik
Regulatory Toxicology and Pharmacology (0273-2300) 106 (2019); 270-277

Vrsta, podvrsta i kategorija rada
Radovi u časopisima, članak, znanstveni

Ključne riječi
mutual recognition ; work-sharing ; reliance ; regulatory harmonisation ; access to medicines

Sažetak
The European regulatory system for approval of medicinal products is globally recognised as a unique platform for regulatory worksharing 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.

Izvorni jezik
Engleski

Znanstvena područja
Farmacija

POVEZANOST RADA