Definition

A document describing the known and unknown safety profile of a medicine and the activities to characterise and minimise risks. Required in the EU and for many products in the US.

Example

The RMP includes safety specification, pharmacovigilance plan, and risk minimisation measures (e.g. educational materials, controlled distribution).

Regulatory source

GVP Module V, FDA REMS when applicable

Common mistakes

Not updating the RMP when new risks are identified or when risk minimisation measures change.

Inspector question

How do you keep the RMP up to date and ensure risk minimisation activities are implemented and monitored?

Related terms