New drug marketing applications: how do EMA and FDA compare?

A newly-published study has compared more than a hundred new drug marketing applications at both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in the period 2014-2016. The study examined the differing outcomes of individual applications at the Agencies in terms of marketing approval, type of approval, and approved indication, including reasons underlying differences.

High concordance

The study found a high level of concordance between the EMA and the FDA in decisions concerning authorisations. High concordance (91%) was found in the Agencies’ initial decisions on marketing approval. Concordance increased to 98% following review of resubmitted or reexamined applications. Concordant outcomes were found as the Agencies often reached the same regulatory results regarding the applications.

Similarities and differences

Both Agencies are committed to global alignment of sound regulatory standards in drug development. Both participate in and have adopted guidelines of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. Similarly, both Agencies have established clusters as areas for information sharing and collaboration around many aspects of medicinal drug product development and regulation.

The study did, however, find several differences between the Agencies and their decision-making process. First, regarding regulatory authority, the study referred to EMA’s approval under exceptional circumstances, an option which does not exist at the FDA. The study also showed other differences in approach to efficacy and safety conclusion and in clinical data submitted in support of an application for authorisation. Other differences were found in approach to indication and descriptions of diagnostic criteria to describe the recommended patient population. Finally, divergent conclusions were reached by the Agencies regarding certain aspects of data integrity in the application, the quality of the drug substance or product, acceptability of the manufacturing process, or applicant compliance with good manufacturing practices.

These findings should however be considered within the scope limitations of the study. The cohort covered a short period of time and focused on new chemical entities and therapeutic biologics. Important categories of biologics were not considered and the cohort reflected prevalent therapeutic areas such as oncology.

The results of this study do, however, show the positive impacts of engagement and collaboration in drug development and approval.


Authored by Elisabethann Wright and Gregoire Paquet


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