Risk management plans for medicines and biologicals
Why RMPs are required
A medicine or biological is approved for registration or inclusion on the basis that in the specified indication(s), at the time of approval, the benefit–risk balance is favourable for the target population.
All products have possible safety concerns, with varying degrees of severity, likelihood of occurrence and impact on the individual patient and public health. Some adverse reactions and risks are unknown at the time of approval (because of the limited duration, size and diversity of the patient population included in clinical trials) and will only be identified and/or characterised during post-approval use.
An RMP describes how safety concerns will be identified and mitigated once the product is supplied, to help ensure the benefit–risk balance remains favourable.