EMA publishes GVP Module V (Revision 2) for public comment

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.)?

You can find the complete draft of Guideline on good pharmacovigilance practices: Module V – Risk-management systems on the Eudralex Vol. 9 website under Draft GVP chapters and annexes for public consultation, and the draft guidance on format of the risk management plan (RMP) in the EU – in integrated format on the EMA Risk-management plans website.  

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