On 31 March 2017, the EMA released a second revision of Module V- Risk Management Systems of Good Pharmacovigilance Practice (GVP) (EMA/838713/2011 Rev 2), together with a revised Guidance on the format of the risk management plan (RMP) in the EU – in integrated format (EMA/PRAC/613102/2015 Rev 2).
During the transition period, RMPs prepared according to earlier GVP Module V Rev 1 will still be accepted; however, all RMPs submitted after 31 March 2018 will require submission in line with Module V Rev 2 and compliance with Rev 2 format.
The new GVP Module V Rev 2 includes major changes, having as primary focus the provision of a risk management system that is proportionate to the identified risks and the potential risks of the medicinal product, and the need for generation of post-authorisation safety data. Namely, the RMP should lay emphasis on those risks which usually justify further analysis in the pharmacovigilance plan (e.g. cumulative reviews of adverse events of interest, post-authorisation safety studies etc) and/or risk minimisation activities (e.g educational materials for healthcare professionals/patients etc).
The definitions of risks and missing information have been reassessed, as well as the approach for considering these safety concerns as part of the RMP. Since this is a dynamic document, certain risks may be reclassified or removed over time, as more data become available. Removal of important identified risks is warranted when the risk is fully characterised and adequately managed. Guidance is given on how missing information should be addressed, with a clarification that lack of data does not necessarily constitute a safety concern. These changes are expected to give rise to a reduction in the number of risks in the RMPs in the future.
Although the overall RMP structure is not changed (same sections as before), important amendments have been made to some of the sections. Explanations as to why risks were classified as both important and unimportant are to be provided in the RMP. A submodule for RMP updates involving new risks and reclassification of risks was also included and a description of missing information should be provided (Part II Module SVII).
Alternatively, other parts of the RMP did not undergo significant changes or were adjusted to a more simplified structure. To describe but a few, only routine pharmacovigilance activities beyond signal detection and adverse reaction reporting should now be included. Important to note, studies imposed by non-EU agencies should no longer be included in EU RMPs (Part III). The list of Annexes is reduced, without the need to append the Summary of Product Characteristics and the Patient Information Leaflet any longer.
Furthermore, RMP content requirements for initial marketing authorisation (MA) applications depending on type of application (e.g. full MA application, generic, hybrid etc) have been revised, so that some of these now have different content requirements based on the risk-proportionate perspective.
Altogether, the notable revision of the GVP Module V and the adapted RMP format provide explanations on previously unclear matters, reconsider risk management principles and stress on adequate risk management in order to add to the scientific quality and adequacy of RMPs, making them consistent with the actual use of the product in a real world environment.
In Azierta we have a team of drug safety experts able to prepare any kind of safety report, helping companies to ensure safety and maintain a good risk-benefit ratio of their medicinal products.
Check out our safety reports website for more details and feel free to contact us, we will be pleased to help you.