Comparison of Regulatory Outcome of EMA and FDA New Medicine Marketing Applications (2014-2016)
Officials of the European Medicines Agency (“EMA”) and the US Food and Drug Administration (“FDA”) published a study on the regulatory outcome of 107 new medicine marketing applications submitted to both agencies in the period 2014 – 2016 (the “Study”* – see attached). The Study shows that there was a high rate of convergence between the decisions on marketing approvals of both agencies.
The decisions upon first submission and review presented the same regulatory outcome for 91.5% of the applications (98 cases out of 107). That impressive figure rose to 98% as a result of resubmitted and reexamined applications (105 cases out of 107). Only two medicines, namely corifollitropin alfa and ataluren, were the subject of discordant marketing authorisation decisions.
The Study also reveals that the broad alignment between the agencies on medicine approvals coexists with some variation in type of marketing authorisation. In addition, some concordant approval decisions exhibited differences in the approved indication.
The divergent outcome upon first submission and review in the 9 cases referred to above were due to a difference in conclusions regarding efficacy (3 out of 9 medicines) and more disparate reasons such as dissimilarities in the submitted clinical data; and differing conclusions about the strength of evidence in support of safety or an applicant’s compliance with good manufacturing practices.
According to the Study, the therapeutic areas that stood out from the perspective of outcome divergence were oncology and hematology.
It is hoped that EMA and FDA officials will carry out similar studies in years to come as these may inform future policy decisions.
*M. Kashoki, Z. Hanaizi, S. Yordanova, R. Vesely, C. Bouygues, J. Llinares and S. Kweder, “A Comparison of EMA and FDA Decisions for New Drug Marketing Applications 2014-2016: Concordance, Discordance and Why”, Clinical Pharmacology and Therapeutics, July 2019.