Conditional Marketing Authorisation

What is Conditional Marketing Authorisation (CMA)?

The approval of a medicine that addresses unmet medical needs of patients on the basis of less comprehensive data than normally required. The available data must indicate that the benefit of immediate availability outweighs the risks of less comprehensive clinical data than normally required. Further, comprehensive clinical data may need to be provided in the future.

Who grants CMA?

The European Medicines Agency (EMA), specifically the Committee for Medicinal Products for Human Use (CHMP) grants CMA (1).

CMA applies to countries served by the European Medicines Agency (EMA), a decentralized agency of the European Union (EU) whose goal is to promote and protect human and animal health. EMA is the European Union’s equivalent to the U.S. Food and Drug Administration (FDA). Countries served by EMA include the 28 EU member states, plus Iceland, Liechtenstein, and Norway.