J Pharmacoepidemiol Risk Manage.  2020 Sep;12(2):70-78.

Current Status of Post-marketing Safety Management in United States, Europe and Japan: Risk Management Plan

• Kim SH
• Kim HJ
• Choi NK

Abstract

Since the limitations of pre-marketing clinical trials, "whole life-cycle managements" that confirm the safety and effectiveness of drugs from the development stage to the post-marketing stage is being emphasized. The United States, Europe, and Japan established risk management systems that reflected the 'E2E: Pharmacovigilance Planning' announced by the International Council of Harmonization (ICH). Based on the E2E guideline, the US Food and Drug Administration (FDA) strengthened the FDA Amendments Act (FDAAA) to provide a legal basis for Post-Marketing Requirement (PMR) and Risk Evaluation and Mitigation Strategy (REMS). The European Medicines Agency (EMA) established Good pharmacoVigilance Practices (GVP) to implement the current form of Risk Management Plan (RMP). In Japan, it was suggested that they should implement RMP based on the case of the adverse event of fibrinogen preparation, and Pharmaceuticals and Medical Device Agency (PMDA) introduced RMP. This paper addresses the post-marketing safety management focusing on RMP in the United States, Europe and Japan, and compare the examples of RMPs of each country for the same drug.

Keyword

Risk management plan; Risk evaluation and mitigation strategy; Real-world data; Post-authorization safety study