EMA Revises Risk Management Guidelines

The European Medicines Agency (EMA) has revised module V of the good pharmacovigilance practices (GVP) on risk management systems based on insights from EMA’s Pharmacovigilance Risk Assessment Committee (PRAC). Public consultation on the revised guidelines is open until May 31, 2016.

The revision clarifies the requirements a risk management plan should focus on “to ensure that a risk-proportionate planning of activities directs resources to areas where the need for additional information and risk minimization is greatest. EMA states that the GVP module V should be read in conjunction with GVP module XVI, which focuses on tools for risk minimization.

EMA is also looking to amend the risk management plan template used by drug developers in order to focus the risk management system and simplify transfer of information to regulators. Public consultation on the revised template is also open until May 31, 2016.