Conditional Marketing Authorisation
An EU pathway allowing early approval with less complete data for medicines addressing unmet medical needs in serious conditions. Conditional authorisations are renewable annually and the holder must provide comprehensive data post-approval. They can convert to standard authorisations when obligations are met.
Technical Context
CMA criteria (Article 14-a of Regulation 726/2004): (1) positive benefit-risk balance (benefits outweigh risks even with incomplete data), (2) likely that the applicant will provide comprehensive data (feasibility of completing studies), (3) unmet medical needs will be filled (no satisfactory treatment available or significant therapeutic advantage), (4) benefit of immediate availability outweighs risk of less data. CMAs are valid for 1 year, renewable annually, and must be converted to standard MA once all obligations are fulfilled. Specific obligations may include: additional clinical trial data, longer follow-up data, additional safety data, or manufacturing data. The EMA's annual renewal review provides a regular checkpoint for benefit-risk reassessment. If obligations are not met, the CMA can be suspended or withdrawn.