Pharma Showing More Interest In Conditional Approvals; Back On EU Expert Group Agenda
Executive Summary
The number of conditional marketing authorizations granted in the EU reached an all-time high in 2016, with eight products approved under the early access pathway. In 2017, so far, a CMA has been granted for Roche’s product Alecensa, and Shire’s Natpar has been recommended for approval under the pathway. In addition, a European Commission expert group that has been exploring how to improve the CMA process and eliminate the negative perceptions surrounding its use is examining a key report on how the pathway is faring.
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