title: Pharmacovigilance in Europe: Place of the Pharmacovigilance Risk Assessment Committee (PRAC) in organisation and decisional processes.
abstract: The new European legislation that came into force in July 2012 reinforced the organisation of pharmacovigilance by setting up a committee in charge of risk assessment for medicines, the Pharmacovigilance Risk Assessment Committee (PRAC). The PRAC has a remit covering the assessment of all aspects of the safety and the risk management of medicinal products for human use in the European Union. It deals with issues regarding pharmacovigilance signals, the periodic evaluation of benefit/risk reports from marketing authorization holders (MAH), risk management plans, post-marketing studies, variations or renewals of marketing authorisations, management of under surveillance drugs lists, inspections for pharmacovigilance reasons and audits of pharmacovigilance systems. The PRAC works with the pharmacovigilance systems of the European Member States, which draw up evaluation reports. These evaluations are circulated and discussed by Member States so as to issue recommendations, which serve as a basis for other European medicines committees, the Committee for Medicinal Products for Human Use (CHMP) or the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh) which then give their opinion. The final decision, which applies to all Member States and to the concerned MAH, lies with the European Commission (EC). This decisional procedure thus rests on coordination involving the PRAC, the CHMP, the CMDh, the EC, the Member States and the pharmaceutical companies. In the 3 years from July 2012, the PRAC has processed nearly 4500 procedures and is still facing an increasing workload.
authors.affiliation: Centre régional de pharmacovigilance, de pharmacoépidémiologie et d'information sur les médicaments, CHU de Limoges, 87042 Limoges, France; Faculté de médecine, université de Limoges, 87042 Limoges, France. Electronic address: marie-laure.laroche@chu-limoges.fr.
authors.forename: Marie-Laure
authors.initials: ML
authors.lastname: Laroche
authors.affiliation: Direction de la surveillance, Agence nationale de sécurité du médicament et des produits de santé (ANSM), 93285 Saint-Denis, France.
authors.forename: Arnaud
authors.initials: A
authors.lastname: Batz
authors.affiliation: Centre régional de pharmacovigilance, de pharmacoépidémiologie et d'information sur les médicaments, CHU de Limoges, 87042 Limoges, France; Faculté de médecine, université de Limoges, 87042 Limoges, France.
authors.forename: Hélène
authors.initials: H
authors.lastname: Géniaux
authors.affiliation: Direction de la surveillance, Agence nationale de sécurité du médicament et des produits de santé (ANSM), 93285 Saint-Denis, France.
authors.forename: Corinne
authors.initials: C
authors.lastname: Féchant
authors.affiliation: Centre régional de pharmacovigilance, de pharmacoépidémiologie et d'information sur les médicaments, CHU de Limoges, 87042 Limoges, France; Faculté de médecine, université de Limoges, 87042 Limoges, France.
authors.forename: Louis
authors.initials: L
authors.lastname: Merle
authors.affiliation: Direction de la surveillance, Agence nationale de sécurité du médicament et des produits de santé (ANSM), 93285 Saint-Denis, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Maison
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D003659:Decision Making, Organizational; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control; D005060:Europe; D005062:European Union; D006801:Humans; D007880:Legislation, Drug; D060735:Pharmacovigilance; D018570:Risk Assessment / Q000458:organization & administration*; D012308:Risk Management / Q000379:methods
keywords: Adverse drug reaction reporting system/organization and administration; Europe; Patient safety/legislation and jurisprudence; Pharmacovigilance; Product surveillance and post-marketing