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Joint analysis from the EMA and the US FDA has shown that the regulatory bodies are highly aligned in the majority of marketing authorization decisions.
Joint analysis from the European Medicines Agency and the US Food and Drug Administration (FDA) has shown that the regulatory bodies are highly aligned in the majority of marketing authorization decisions.
In an Aug. 16, 2019 press release, EMA highlighted the alignment finding from the joint analysis, which also assessed the applications for which the agencies had different results. Comparing new medicine applications between 2014 and 2016, the analysis revealed that 90% of decisions were aligned. In those decisions that were different, the most common reasoning was variances in conclusions about efficacy. The second most common reason why the agencies had divergent decisions was differences in the clinical data submitted.
“The high rate of convergence in the authorization of new medicines at EMA and 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 marketing authorizations, while both agencies evaluate applications independently of each other,” said Zaide Frias, head of EMA’s human medicines evaluation division in a news release. “Our cooperation clearly supports both agencies in achieving a common goal of maximizing patient access to safe, effective, and high-quality medicines in both regions.”
An open-access article discussing the study is available in the journal Clinical Pharmacology and Therapeutics.