Description
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EU Risk Management Plan (RMP) Development
The Risk Management Plan is a mandatory component of every Marketing Authorization Application in the European Union. An effective RMP demonstrates your comprehensive understanding of your product’s safety profile and your commitment to ongoing pharmacovigilance throughout the product lifecycle.
Editverse provides complete RMP development and lifecycle management services from initial MAA submission through post-authorization updates, ensuring your risk management strategy evolves with your product’s safety knowledge.
📋 What is an EU Risk Management Plan?
The RMP is a detailed description of the risk management system for a medicinal product, including:
- 🔍 Safety Specification – Comprehensive characterization of the safety profile
- 📊 Pharmacovigilance Plan – Activities to monitor identified and potential risks
- 📋 Risk Minimization Measures – Actions to prevent or reduce risks
- 📈 Effectiveness Evaluation – Assessment of risk minimization success
📜 Regulatory Framework
| Regulation/Guideline | Requirement |
|---|---|
| Regulation (EU) 726/2004 | Centralized procedure requirements |
| Directive 2001/83/EC | National and decentralized procedure requirements |
| GVP Module V | Risk Management Systems – detailed RMP guidance |
| GVP Module XVI | Risk Minimization Measures guidance |
| EMA RMP Template | Current RMP format requirements (Rev. 2.0.1) |
📊 RMP Modules and Structure
| Module | Part | Content |
|---|---|---|
| Part I | Product Overview | Product details, epidemiology, indication overview |
| Part II | Safety Specification | Module SI-SVIII including epidemiology, nonclinical, clinical trial exposure, post-marketing data |
| Part III | Pharmacovigilance Plan | Routine and additional PV activities, PASS studies |
| Part IV | Post-Authorization Efficacy Studies | PAES plans if required |
| Part V | Risk Minimization Measures | Routine and additional RMMs, effectiveness evaluation |
| Part VI | Summary of RMP | Public-facing summary for EPAR |
| Part VII | Annexes | SmPC, PL, mock-ups, educational materials, DHPC templates |
🔍 Safety Specification Components (Part II)
- ✅ Module SI – Epidemiology of indication(s)
- ✅ Module SII – Nonclinical part of safety specification
- ✅ Module SIII – Clinical trial exposure
- ✅ Module SIV – Populations not studied in clinical trials
- ✅ Module SV – Post-authorization experience
- ✅ Module SVI – Additional EU requirements (ASMF, environmental risk)
- ✅ Module SVII – Identified and potential risks
- ✅ Module SVIII – Summary of safety concerns
📋 Service Options
| Service | Description | Timeline |
|---|---|---|
| Initial RMP (MAA) | Complete RMP for new marketing authorization application | 10-14 weeks |
| RMP Update | Periodic update (new data, PSUR alignment, PRAC request) | 4-8 weeks |
| Variation-Triggered Update | RMP revision for Type II variation or line extension | 4-6 weeks |
| PRAC Response | Response to PRAC questions on RMP | 2-4 weeks |
| RMP Gap Analysis | Assessment of existing RMP against current requirements | 2-3 weeks |
⚙️ Development Workflow
| Phase | Activities | Duration |
|---|---|---|
| 1. Risk Assessment | Safety data review, risk identification, safety concern categorization | Week 1-3 |
| 2. Safety Specification | Draft all safety specification modules | Week 3-6 |
| 3. PV & RMM Plans | Develop pharmacovigilance and risk minimization strategies | Week 6-9 |
| 4. Annexes | Prepare educational materials, DHPC templates if needed | Week 8-10 |
| 5. Internal Review | PV expert and regulatory review | Week 10-11 |
| 6. Sponsor Review | Client review and comment resolution | Week 11-13 |
| 7. Finalization | Final QC, EMA template compliance check | Week 13-14 |
✨ Why Choose Editverse
| Feature | Benefit |
|---|---|
| GVP Expertise | Writers trained in GVP Modules V and XVI requirements |
| PRAC Experience | Familiarity with common PRAC questions and expectations |
| SmPC/PL Alignment | Ensuring consistency between RMP and product labeling |
| Template Compliance | Up-to-date with latest EMA RMP template requirements |
| Lifecycle Support | Ongoing RMP maintenance and update services |
📦 Deliverables
- ✅ Complete RMP Document – All parts and modules per EMA template
- ✅ Summary of RMP – Public-facing version for EPAR
- ✅ Risk Minimization Materials – Educational materials, HCP guides if required
- ✅ DHPC Templates – Direct Healthcare Professional Communication drafts
- ✅ Version Control – Complete change tracking and version history
📞 Get Started
Contact us to discuss your product’s risk management needs:
📧 Email: co*****@*******se.com
🌐 Web: editverse.com
Pricing provided in your local currency. Bundled with MAA writing services for comprehensive submission support.
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