EMA-FDA display ‘high degree’ of alignment on approvals

By Ben Hargreaves

- Last updated on GMT

(Image: Getty/Cunaplus_M. Faba)
(Image: Getty/Cunaplus_M. Faba)

Related tags Ema Fda Harmonisation Mutual recognition

A joint study conducted by the EMA and FDA showed that marketing approval decisions were 90% shared for new medicines, as the agencies push for a closer working relationship.

Last month,  the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) announced the completion of their mutual recognition agreement​, which saw both agencies recognize the veracity of each other’s good manufacturing practice (GMP) inspections.

At the end of last week​, the EMA posted the results of joint analysis between the two agencies, which found that both reached the same conclusion on 90% of 107 medicines submitted for approval.

According to a statement by Zaide Frais, head of EMA’s human medicines evaluation division, “The high rate of convergence in the authorization of new medicines at EMA and the FDA is the result of expanded investment in dialogue and cooperation since 2003 and has fostered alignment between the EU (European Union) and the US with respect to decisions on marketing authorizations, while both agencies evaluate applications independently of each other.”

The data was gathered between 2014 and 2016, and was the first such analysis conducted by the two agencies related to marketing authorizations.

When analysis was conducted on the reasons for the 10% divergence, the most common reason was found to be differences in conclusions regarding the efficacy of the medicine.

In addition, ‘quality differences’ was referenced as being another factor in the variance of regulatory opinion, which included differing assessments on “the quality of the drug substance or product, acceptability of the manufacturing process, or applicant compliance with GMP.”

The report concluded that the high level of accordance between the agencies suggested that efforts to harmonize across the field were resulting in similar findings.

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