Eudralex Volume 9: The European Medicines Agency (EMA ) recently published GVP (Guideline on Good Pharmacovigilance Practices) Module V (Revision 2, major revision) for comment. The GVP-Module V covers the topic risk management. Aditionally the template for preparation of a Risk Management Plan (RMP) has been revised.
Deadline for comments for both documents is May 31, 2016.
The following Changes have been incorporated in the document:
further clarification of what RMPs should focus on in relation to an important identified or important potential risk and missing information;
removal of duplication within GVP Module V;
removal of duplication of information in other guidance documents;
further guidance on the expected changes in the RMP during the life cycle of the product;
updated requirements for different types of initial marketing authorisation applications, with the aim to create risk-proportionate, fit for purpose RMPs.
Furthermore, the EMA addressed questions on which the agency seeks specific feedback by means of the public consultation:
The updated risk definitions and guidance on Part II Module SVII of the RMP may lead, in the post-authorisation phase, to a list of safety concerns in the RMP that is a subset of the list of the product safety concerns as defined in the PSUR. What should be the priority of the GVP Module V: a focused RMP list of safety concerns or the full alignment with the PSUR content?
Should studies conducted by the MAH but neither required nor imposed by the competent authority (previously classified as category 4 studies) be included, for information, in the RMP Annex 2?
Should the additional risk minimisation materials as they were distributed in the Member States be included in the annexes of the RMP (i.e. RMP annex 6 – part B)?
Should section V.B.10 be maintained or deleted (i.e. in the light of the RMP terminology described in V.A.1.)?