The EMA has issued the revised Good Pharmacovigilance Practices (GVP) Module V on Risk Management Systems (EMA/838713/2011 Rev 2) and the accompanying Risk Management Plan (RMP) Template. This version of Module V carries significant changes based on a thorough review of RMPs by the Pharmacovigilance Risk Assessment Committee (PRAC).
The aim of an RMP is to document the risk management system considered necessary to identify, characterise and minimise a medicinal product’s important risks so it is good to see that the revisions include additional explanation of what RMPs should focus on in relation to an important identified or important potential risk and missing information.
As knowledge on a medicinal product’s safety profile increases over time, it is appropriate and necessary that the RMP evolves so the revisions include further advice on the expected changes in the RMP during the product lifecycle.
The changes in Revision 2 are major and many, and also include removal of replication of information within the Module and other guidance documents. The requirements for different types of initial marketing authorisation applications (MAA) has been amended. This aims to ensure risk-proportionate RMPs are created. The RMP template for initial MAAs has been updated in parallel.
RMPs submitted for initial MAAs and D121 responses using GVP Module V Rev 1 will be accepted until 30th September 2017. All other RMP submissions (including D91 responses for an initial application under accelerated assessment) will be accepted for one further year until 31st March 2018.
To access the GVP Module V on Risk Management Systems (EMA/838713/2011 Rev 2), click here.