Regulatory experience of handling Risk Management Plans (RMPs) for medicinal products in the EU

Abstract

Introduction: Risk Management Plans (RMPs) aim to optimize a medicinal product’s benefit/risk balance for the individual patient and the target population. Despite differences in regulatory RMP requirements between jurisdictions worldwide, their ultimate aim is to protect public health. Areas covered: The review presents findings of different RMP requirements by different regulatory authorities and additional risk minimization measures (issued between January 2010 and December 2018) indicate how RMPs and additional risk minimization measures translate into actions to protect public health within the European Union (EU) member states and worldwide. Areas covered also include the different International Council for Harmonization (ICH) regional requirements of RMPs by the different regulatory authorities as well as data regarding the number of RMP assessments carried out by the EMA, FDA and Japan, and number of safety communications issued in Malta (taken as an example of a typical small EU member state) and in the United States of America (USA). Expert opinion: The EU legislation adopted in 2010 required RMPs to be included in all new applications for medicinal products in the EU, both for EU centrally authorized and nationally authorized medicinal products. Lessons learnt by EU regulators during this process are discussed in this review.