Definition

Evaluation of the positive therapeutic effects of a medicine versus its risks; must be favorable for approval and maintained post-approval.

Example

PRAC assessment that benefits outweigh risks with updated SmPC.

Regulatory source

GVP Module V, IX; CHMP benefit-risk template

Common mistakes

Treating benefit-risk as one-time rather than ongoing.

Inspector question

How do you monitor and document benefit-risk over the product lifecycle?

Related terms