What is it about?

Review outcomes in terms of approvals/rejections between the EMA and the US FDA are rather more aligned than not - this is an important finding as the notion that they differ significantly sometimes is forwarded in the public debate. Having said that, despite consistency in submitted indications, there was lack of concordance in approved indications.

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Why is it important?

A reasonable expectation is that regulatory actions and outcomes should not differ significantly between, for instance, the FDA and EMA, given that both regulatory bodies evaluate very similar, if not identical, data packages and regulate for similar types of populations. Differences (in approved indications) can have considerable implications at the patient level. The same drug can be available without restrictions in one regulatory jurisdiction but with restrictions in another. This is of special concern when a drug is novel and first in class with no comparable therapeutic alternatives available.


A deeper understanding of the underlying reasons for when the same indication was submitted but different indications were approved could illuminate the differences in significance the two agencies attach to the various components in their respective benefit-risk analyses. Bearing in mind that the two agencies have had a close collaboration for many years, and that regulatory decision making should be based on science and evidence, there may be important learnings for drug developers to uncover, helping them to avoid future situations in which the same data set would render different outcomes.

Thomas Kuhler
Sanofi SA

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This page is a summary of: To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time peri..., BMJ Open, November 2019, BMJ,
DOI: 10.1136/bmjopen-2018-028677.
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