EMA Proposes Major Changes to Pharmacovigilance Risk Management System Guidelines

4 March 2016

EMA has proposed major changes to its good pharmacovigilance practices (GVP) module on risk management systems. EMA wants to implement the modifications to bring the guidelines in line with its current thinking, which has evolved over the past three years as it has gained experience with the key areas of focus in risk management plans (RMPs).

GVP module V, which covers RMPs, was first released in 2012, the same year that EMA created the Pharmacovigilance Risk Assessment Committee (PRAC). The committee, which reviews RMPs as part of its responsibilities, has accrued knowledge of how best to approach plans over the past few years. Revision 2 of the GVP module is the first version of the document to benefit fully from the knowledge. By incorporating the experience into its guidelines, EMA thinks it can better advise companies about the creation of RMPs, which must be approved by regulators in advance of a drug being authorized.

In opening the revised text to the industry for consultation, EMA has selected four topics about which it is particularly keen to receive feedback. Some of the issues highlighted by EMA for discussion relate to its attempt to refocus RMPs to ensure all actual and potential safety concerns regarding a product are covered adequately by the plan. EMA, which devotes three pages of the text to these “identified and potential risks,” is asking if people want RMPs to provide a focused list of safety concerns or a comprehensive catalog that aligns with periodic safety update reports (PSURs).

As it stands, EMA thinks the proposed risk definitions and guidance could, in the post-authorization stage, result in RMPs being associated with a list of safety concerns that is a subset of those defined in the PSUR. Whether this is desirable is at the heart of one of EMA’s four questions for the industry. The other questions cover whether studies conducted voluntarily, as opposed to at the behest of the competent authority, and extra risk minimization materials should be included in the annexes of the RMP. EMA is also seeking advice on whether to cut a whole section in light of its new terminology. 

The module V consultation is taking place in parallel to a review of proposed changes to a template for RMPs. EMA has revised the template to bring it into line with its planned changes to module V, notably its attempts to create a more focused risk management system. By making the changes to the template, EMA thinks it can simplify the way companies present risk management information to regulators. The comment periods on both documents are due to close on 31 May, positioning EMA to aim to have a finalized version of module V come into effect in the third quarter of 2016.

EMA Statement, Draft Guidelines, Draft Template

Source: RAPS , EMA