European Union pharmacovigilance capabilities: potential for the new legislation

Abstract

European Directives and Regulations introduced between late 2010 and 2012 have substantially overhauled pharmacovigilance processes across the European Union (EU). In this review, the implementation of the pharmacovigilance legislative framework by EU regulators is examined with the aim of mapping Directive 2010/84/EU and Regulation EC No. 1235/2010 against their aspired objectives of strengthening and rationalizing pharmacovigilance in the EU. A comprehensive review of the current state of affairs of the progress made by EU regulators is presented in this paper. Our review shows that intense efforts by regulators and industry to fulfil legislative obligations have resulted in major positive shifts in pharmacovigilance. Harmonized decision making, transparency in decision processes with patient involvement, information accessibility to the public, patient adverse drug reaction reporting, efforts in communication and enhanced cooperation between member states to maximize resource utilization and minimize duplication of efforts are observed.

Introduction

“…By utilising these comparative materials, we were able to see the relative strengths as well as the chronic problems of the EU pharmacovigilance system . Drawing on desk-and field-based research, these findings complement and add significantly to primarily theoretical discussions about the system (see Borg et al . 2015;Calvo and Zuňiga 2014) .…”

Seguimiento e impacto de la divulgación de cinco alertas sanitarias de medicamentos en Colombia

“…Con esta intervención educativa y basada en la farmacovigilancia, dirigida a médicos prescriptores en temas de interés de seguridad de los medicamentos se logró reducir en promedio un 10,5% las prescripciones de riesgo por su pobre perfil de riesgo/beneficio, que debe favorecer a un importante número de pacientes en los que se evitarían las complicaciones que llevaron a que las agencias reguladoras tomaran medidas para disminuir su utilización (1,2,5,(14)(15)(16).…”

The ENCePP Code of Conduct: A best practise for scientific independence and transparency in noninterventional postauthorisation studies

“…Since its beginning, the ENCePP network has served as support for the European regulatory environment in the field of epidemiology . The ENCePP network has also helped to facilitate the introduction of amended regulatory concepts and amended frameworks specifically in the field of epidemiology for the conduct of postauthorisation safety studies (PASS), and especially following also regulatory requirements coming into force with the EU pharmacovigilance legislation in 2012 . Evolution of the ENCePP network continues to support the work of EU regulatory agencies mirroring also the increased demand for generation of post‐approval data .…”

“…1,15,16 The ENCePP network has also helped to facilitate the introduction of amended regulatory concepts and amended frameworks specifically in the field of epidemiology for the conduct of postauthorisation safety studies (PASS), and especially following also regulatory requirements coming into force with the EU pharmacovigilance legislation in 2012. [17][18][19] Evolution of the ENCePP network continues to support the work of EU regulatory agencies mirroring also the increased demand for generation of post-approval data. 17,20 ENCePP guidance documents are seen as important resource and form part of recommended references and resources of regulatory guidance such as GVP Modules.…”