New study shows EMA and FDA aligned on marketing authorisations

ema and fda

New study shows EMA and FDA aligned on marketing authorisations

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are aligned in more than 90% of marketing authorizations (MA) for new drugs, according to a new study from EMA and FDA officials comparing 107 new medicine applications at the two agencies between 2014 and 2016.

This is the first analysis by EMA and the FDA that compares the agencies decisions related to MA. “Overall, 84% of the applications were approved on their first submission by both the EMA and the FDA, with the EMA having a higher rate of “first review cycle” approval (92%) compared with the FDA (85%). Taking account of the resubmitted and reexamined applications, the agencies had final discordant MA decisions for two drugs.”

The most common reason for diverging decisions at the two agencies were differing conclusions about efficacy. Differences in clinical data submitted in support of an application were the second most common root of divergence.

According to Zaide Frias, head of the EMA’s human medicines evaluation division: “The high rate of convergence in the authorisation of new medicines at EMA and the FDA is the result of expanded investment in dialogue and cooperation since 2003 and has fostered alignment between the EU and the US with respect to decisions on MA, while both agencies evaluate applications independently of each other,”.

Over the past 15 years, the agencies have established joint working groups and forums for information sharing and collaboration around many aspects of medicine development and regulation. This collaboration includes ‘clusters’ on special topics and therapeutic areas, in addition to parallel scientific advice and protocol assistance.

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