CMA | Conditional Marketing Authorisation

Q: CMA | Conditional Marketing Authorisation

Conditional Marketing Authorisation requiring further data Conditional Marketing Authorisation (CMA) is a European mechanism that enables early access to a medicine based on incomplete data, when the potential benefit outweighs remaining uncertainties. CMA is typically granted for serious, rare diseases or public health emergencies. The marketing authorisation holder must commit to providing additional data within an agreed timeframe to confirm the product’s safety and efficacy profile.

Conditional Marketing Authorisation requiring further data

Conditional Marketing Authorisation (CMA) is a European mechanism that enables early access to a medicine based on incomplete data, when the potential benefit outweighs remaining uncertainties.

CMA is typically granted for serious, rare diseases or public health emergencies.

The marketing authorisation holder must commit to providing additional data within an agreed timeframe to confirm the product’s safety and efficacy profile.