P29 Conditional Marketing Authorization – Becoming Increasingly More Common But Increasingly Less Relevant
The European Medicines Agency (EMA) can grant a Conditional Medicines Authorization (CMA) for medicines that treat severe diseases based on less comprehensive clinical data than usual, pending the collection of more comprehensive data post-authorization. This research evaluates how the number of CMAs have evolved over time and their conversion to successful reimbursement.
Source: Value in Health - Category: International Medicine & Public Health Authors: R. Macaulay, M. Bear Tags: Impact of Regulatory Affairs on Access Source Type: research