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EMA/FDA Analysis Shows High Degree of Alignment in Marketing Application Decisions Between EU and US

The study also looked at applications for which the two agencies had different outcomes
23 Aug 2019
Bioethics, legal and economic issues

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) are aligned in more than 90% of marketing authorisation decisions for new medicines. This is one of the findings of a joint EMA/FDA analysis comparing decisions on 107 new medicine applications at the two agencies between 2014 and 2016.

The study also looked at applications for which the agencies had different outcomes in terms of type of approval and indication. The most common reason for diverging decisions at the two agencies were differences in conclusions about efficacy. Differences in clinical data submitted in support of an application were the second most common root of divergent FDA and EMA decisions. 

Expanded investment in dialogue and cooperation between two agencies since 2003 has fostered alignment between the EU and the US with respect to decisions on marketing authorisations, while both agencies evaluate applications independently of each other.

This is the first analysis by the EMA and FDA that compares the agencies’ decisions related to marketing authorisations. There have been previous comparisons of regulatory approvals by the EMA and FDA, but they have been limited. This is the most comprehensive study to date.

This examination of a 3‐year cohort of marketing applications reviewed by both the EMA and the FDA compared the agencies’ approval/licensing decisions, types of approval, and approved indications, as well as the underlying reasons for different decision reached. The focus on reasons for differences in decisions is a feature not previously addressed and provides more insight into factors underlying how the agencies approach decisions.

Some differences were observed in the clinical data due to the difference in timing of submissions (more applications were submitted to the FDA before they were submitted to EMA). Compared to the FDA, EMA often reviewed applications including additional clinical trials or, particularly for oncology medicines, more mature data from the same clinical trial. In those instances, EMA was more likely than the FDA to grant standard approval, a broader indication, or use of a medicine as first-line therapy.

Over the past decade, EMA and the FDA have established joint working groups and several forums for information sharing and collaboration around many aspects of medicine development and regulation, including ‘clusters’ on special topics and therapeutic areas, as well as parallel scientific advice and protocol assistance. These groups bring together experts for example on plans for manufacturing or clinical site inspections, development of medicines for children, oncology products, biostatistics, rare diseases and vaccines. While these groups are not forums for shared decision-making, the strong alignment in decisions on marketing authorisations suggests that they may be contributing to alignment on regulatory science.

Most of the information used for the study was sourced from EMA’s publicly available European Public Assessment Reports and FDA reviews, which contain the agencies’ rationale for their decisions on applications. 

The high concordance of EMA and FDA decisions suggests ongoing efforts to collaborate on regulatory science may be contributing to more global harmonisation in the field, including clinical pharmacology and translational science as applied to drug development. The EMA and the FDA had high concordance (91–98%) in decisions on marketing approvals. This high rate of concordance suggests that engagement and collaboration on regulatory science has a positive impact.

The article is available through open access in Clinical Pharmacology and Therapeutics.



Kashoki M, Hanaizi Z, Yordanova S, et al. A Comparison of EMA and FDA Decisions for New Drug Marketing Applications 2014–2016: Concordance, Discordance, and Why. Clinical Pharmacology & Therapeutics; First published 15 July 2019. https://doi.org/10.1002/cpt.1565


Last update: 23 Aug 2019

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