Posted on 2/13/2018 10:00 AM
All EU Risk Management Plans (RMPs) submitted to the European Medicines Agency (EMA) on or after March 31, 2018 must be submitted using the updated EMA template aligned with Guideline on good pharmacovigilance practices (GVP) Module V Rev 2. The updated EU RMP template is following an industry trend in which bulky, repetitive documents are being trimmed down to be lean and streamlined to accompany submission documents.
Some of the major changes from GVP Module V Rev 2 include:
- Further clarification on what RMPs should focus on in relation to safety concerns (important identified risks, important potential risks, and missing information).
- Removal of duplication within the RMP.
- Removal of duplication of information among submission documents.
- Additional guidance on the expected changes in the RMP during the life cycle of the product.
- Updated requirements for different types of initial marketing authorization applications, with the aim to create risk-proportionate RMPs.
MMS has written over 400 RMPs (EU, local, and company‑specific) within the last four years. We have revised our RMP templates to align with the latest guidance and have created a process to ease the client through the transition. MMS is familiar with EMA expectations; therefore, we can provide guidance to cross‑functional team members on how to interpret the new guidance for updated and initial EU RMPs, including reassessment of safety concerns. In addition, we work with our clients to create RMP templates that both meet their company needs and that also follow the updated GVP Module V guidance. At MMS, we have an entire department dedicated to writing RMPs with the experience to navigate this transition. Are you ready?
Head of Medicines Agencies. Guideline on Good Pharmacovigilance Practices. www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129134.pdf.
European Medicines Agency. Guidance on the Format of the Risk Management Plan (RMP) in the EU – in Integrated Format. www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2017/03/WC500224771.pdf+.