EMA Releases Guidance on Risk Management Plans

| 12 November 2012

The European Medicines Agency (EMA) has released a huge number of new guidance documents regarding the format of risk-management plans (RMPs). The revised documents are an integral part of its new strategy on pharmacovigilance, which is the result legislation passed earlier in the year that overhauled the way postmarket surveillance is conducted in the EU.

The new guidances-16 in all-relate to a wide number of topics and product types, and provide an overview of how sponsors should fill out the new risk-management plan forms in the EU.

• Guidance on format of the risk-management plan in the European Union - in integrated format
• Guidance on format of the risk-management plan in the European Union for generics
• Guidance on format of the risk-management plan in the European Union part I: Product overview
• Guidance on format of the risk-management plan in the European Union part II: Module SI - Epidemiology of the indication(s) and target population
• Guidance on format of the risk-management plan in the European Union part II: Module SII - Non-clinical part of the safety specification
• Guidance on format of the risk-management plan in the European Union part II: Module SIII - Clinical-trial exposure
• Guidance on format of the risk-management plan in the European Union part II: Module SIV - Populations not studied in clinical trials
• Guidance on format of the risk-management plan in the European Union part II: Module SV - Post-authorisation experience
• Guidance on format of the risk-management plan in the European Union (EU) part II: Module SVI - Additional EU requirements for the safety specification
• Guidance on format of the risk-management plan in the European Union part II: Module SVII - Identified and potential risks
• Guidance on format of the risk-management plan in the European Union part II: Module SVIII - Summary of the safety concerns
• Guidance on format of the risk-management plan in the European Union part III: Pharmacovigilance plan
• Guidance on format of the risk-management plan in the European Union part IV: Plans for post-authorisation efficacy studies
• Guidance on format of the risk-management plan in the European Union part V: Risk-minimisation measures
• Guidance on format of the risk-management plan in the European Union part VI: Summary of activities in the risk-management plan by product
• Guidance on format of the risk-management plan in the European Union part VII: Annexes