US FDA-EMA mutual recognition: Two down, two to go

By Ben Hargreaves contact

- Last updated on GMT

(Image: Getty/SurkovDimitri)
(Image: Getty/SurkovDimitri)

Related tags: Mutual recognition, Harmonisation, Germany, Slovakia

Luxembourg and the Netherlands added to the US FDA-EMA mutual recognition agreement, which leaves just Germany and Slovakia to be verified.

The deadline for the last two countries to be added to the European Medicines Agency (EMA) and US Food and Drug Administration (FDA)’s mutual recognition agreement is July 15.

At present, this means that the FDA can rely on the inspections of 26 European Union member states to determine whether sites are current good manufacturing practice (cGMP) compliant.

The original announcement on the mutual recognition framework between the two agencies was made in March 2017​. Through this, the EMA recognises that the FDA’s inspections are of sufficient quality to negate duplicate inspections.

Following this, the EMA has been steadily releasing the countries​ that have successfully added to the mutual recognition agreement, which sees the FDA acknowledge the veracity of EU member countries’ inspections.

According to an EMA statement, “The agreement is underpinned by robust evidence on both sides of the Atlantic that the EU and the US have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines.”

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