The concept of Risk Management was first standardized in the ICH E2E document in 2004 which defines Pharmacovigilance Planning accepted in all 3 ICH regions. In 2006 the European Union introduced Risk Management Plans (RMP) and it was updated with the introduction of the Good Pharmacovigilance Practice legislation in 2010/2012. The RMP guidance had a major revision in 2017 with substantial revisions to the layout and content
In the European Union (EU), companies must submit an RMP to the Agency at the time of application for a marketing authorization.

RMPs in the EU must be continually modified and updated throughout the lifetime of the medicine as new information becomes available. In particular companies need to submit an updated RMP:

  • at the request of EMA or an National Competent Authority

  • whenever the risk-management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit-risk profile or as a result of an important pharmacovigilance or risk-minimization milestone being reached.

When justified by risk, the competent authority can also specify a date for submission of the next RMP as a condition of the marketing authorization in exceptional cases.

Although the concept is defined by the EU and EMA it has been adopted many places in the world. Countries outside the European Union that require a Risk Management Plans include Israel, Mexico and Brazil.;

RMP structure

Part I Product(s) overview

Part II Safety specification Module SI Epidemiology of the indication(s) and target population(s)

Module SII Non-clinical part of the safety specification

Module SIII Clinical trial exposure Module SIV Populations not studied in clinical trials

Module SV Post-authorisation experience

Module SVI Additional EU requirements for the safety specification

Module SVII Identified and potential risks

Module SVIII Summary of the safety concerns

Part III Pharmacovigilance plan (including post-authorisation safety studies)

Part IV Plans for post-authorisation efficacy studies

Part V Risk minimisation measures (including evaluation of the effectiveness of risk minimisation activities)

Part VI Summary of the risk management plan

Part VII Annexes



More information is available here: EU GVP module 5 - Risk Management Systems