Introduction
The European Medicines Agency has revised the Good Pharmacovigilance
Practices (GVP) Module V on Risk Management Systems. The revised module (Revision 02) is effective from March 31, 2017. These revisions to the GVP Module V are intended to provide a more concise and clear description of risk management and how safety risks evolve through a product’s lifecycle based on the evidence from a variety of sources. The guidance is updated in parallel to an amended Risk
Management Plan (RMP) template for initial marketing authorization application.
Major changes in revision 02 of RMP guideline
• Clarification of what RMPs should focus on in relation to an important
identified or important potential risk and missing information
• Removal of duplication of information within GVP Module V
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
• An amended RMP template for initial marketing authorisation application
Transitional arrangements for RMP version 02
According to EMA, RMPs submitted for initial marketing authorization applications and D121 responses applying GVP Module V Rev 1 will be accepted for a further 6 months, and all other RMP submissions (including D91 responses for an initial application under accelerated assessment) will be accepted for one further year until 31 March 2018. Thus, all RMPs submitted after 31 March 2018 will be required to be submitted in accordance with revised guideline of RMP and comply with the Revision 02 format.
Conclusion
The revised guideline of the RMP and the RMP template provide substantive changes for RMPs and provide a welcome risk proportionate approach. The documents have provided clarification on previous grey areas and allow clearly for a change to the risk profile over time with the
opportunity to remove or modify risks as
appropriate. As a result it is likely that a more scientifically valuable RMP will be created which is better adapted to considering the use of the product in the real world setting over time.
References
[1] Guideline on good pharmacovigilance practices (GVP) Module V – Risk
management systems (Rev 1) Dated 15 April 2014 Available at https://www.scribd.com/document/33 6 4 4 0 8 3 3 / Guideline – o n – good -pharmacovigilance-practices-GVP Module – V- Risk – management -systems-Rev-1-pdf
[2] Guideline on good pharmacovigilance practices (GVP) Module V – Risk
management systems (Rev 2) Dated 28 March 2017 Available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129134.pdf
[3] NEW! EMA Guidance on RMPs in the EU Dated 03 April 2017 Available at http://www.ubc.com/blog/new-emaguidance-rmps-eu.
