What approach have other regulators taken to Risk Management Planning?
In both Europe and the United States, regulators made the decision to implement a Risk Management Planning component as well as the E2E document on Pharmacovigilance Planning. In Europe, the European Union (EU) implemented the Guideline on Risk Management Systems for Medicinal Products for Human Use including the EU-RMP in November of 2005. In the United States the Food and Drug Administration (US FDA) published three separate guidance documents on Premarketing Risk Assessment, Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment and Development, and Use of Risk Minimization Action Plans (RiskMAPs), also in 2005. Further to recent updates to the Food and Drugs Act (the Food and Drugs Amendments Act – FDAAA), the US FDA is now requiring Risk Evaluation and Mitigation Strategies (REMs) for certain products with “exceptional circumstances” although these exceptional circumstances have not yet been defined.