Risk management

Medicines in the European Union (EU) are authorised on the basis that their benefits outweigh their risks for the target population. However, not all potential or actual adverse reactions are identified at the time of initial marketing authorisation. The aim of risk management is to address uncertainties in the safety profile at different points in the product lifecycle, and to plan accordingly.

Marketing authorisation applicants are required to submit risk management plans (RMPs), which include information on a medicine's safety profile and plans for pharmacovigilance activities designed to gain greater knowledge. They also explain how risks will be minimised in patients and how those efforts will be measured.

For full details on the risk management plan format and contents, see:

Submitting a risk management plan

Companies must submit an RMP at the time of applying for a marketing authorisation, though in some circumstances they may omit certain parts.

For medicines that diid not have an RMP at the time of marketing authorisation, the European Medicines Agency (EMA) or national competent authorities (NCAs) may require an RMP to address safety concerns.

All RMPs must include a summary, which distils the technical detail into a public-friendly format. For centrally authorised medicines, EMA publishes the RMP summary alongside the European public assessment report.

RMPs need to be continually modified and updated as new information becomes available. Companies need to submit an updated RMP:

  • at the request of EMA or an NCA;
  • whenever the risk management system is modified, especially as the result of new information that may significantly change the benefit / risk profile or as a result of reaching an important pharmacovigilance or risk-minimisation milestone.

Companies no longer need to submit the RMP to EMA in structured electronic format (known as EU-RMP Annex 1), as EMA has suspended maintaining the database for these files.

European risk management strategy

The EU Network Pharmacovigilance Oversight Group oversees performance of the pharmacovigilance system, implementing measures that allow for the early detection, assessment, minimisation and communication of risks of medicines in Europe throughout their lifecycle.

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