Evaluation of the effectiveness of risk minimization measures

Recent Developments in EU and US Pharmacovigilance Legislation

“…Therefore, EU and US legislations primarily tend toward the intensification of pharmacovigilance, moving from passive to proactive, although the usefulness of the tools provided by the legislation is controversial [13][14][15][16][17][18]. The second trend is a partial harmonization of the different pharmacovigilance systems in order to simplify the sponsors' activities and increase the efficacy of pharmacovigilance [19,20].…”

Proactively managing the risk of marketed drugs: experience with the EMA Pharmacovigilance Risk Assessment Committee

“…In this work the PRAC has focused on ensuring feasible, evidence-based and risk-proportionate planning 4 .…”

Community pharmacists’ knowledge and perceptions on risk management plans in the Southern Region of Portugal

“…This was the foundation for regulatory requirements related to risk management plans (4). The compulsory introduction of the risk management plan (RMP) in Europe, beginning in 2005, has ensured greater proactivity in pharmacovigilance and post-authorization benefit-risk management (3). The RMP, submitted by the marketing authorization holder, is presently defined as 'a set of pharmacovigilance activities designed to identify, characterize, prevent, or minimize risks relating to medicinal products, including the effectiveness of those activities and interventions' (p. 2) (5).…”

“…It is well established that, when a drug is authorized, not every risk is identified, and drug-related hazards can only be completely characterized in the post-marketing phase (3,4). This was the foundation for regulatory requirements related to risk management plans (4).…”