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Pharma Showing More Interest In Conditional Approvals; Back On EU Expert Group Agenda

 
• By Neena Brizmohun

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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Interest in the conditional authorization pathway is rising, says the EMA • Source: Shutterstock

The number of conditional marketing authorizations granted in the EU last year rose to an all-time high, against a backdrop of efforts by regulators to improve the early access pathway and eliminate the negative perceptions that have surrounded its use.

Eight products received a CMA in 2016, twice as many than the highest number of CMAs granted in any given year since 2006, when the pathway was first used. Some...

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