Mutual recognition: US to accept GMP inspections from eight EU regulators

By Dan Stanton contact

- Last updated on GMT

GettyImages/Fredex8
GettyImages/Fredex8
The US FDA says the recognition of facility inspections from eight European regulatory authorities is an “unprecedented and significant step forward” in the transatlantic Mutual Recognition Agreement.

Earlier this year​​, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) signed a mutual recognition agreement​​ (MRA), to reduce duplicate audits by allowing recognition of each other’s facility inspection good manufacturing practice (GMP) data.

And this week the agencies announced the MRA has entered an operational phase, with the outcomes of inspections carried out by eight EU Member States – Austria, Croatia, France, Italy, Malta, Spain, Sweden, and United Kingdom – to be recognised by the FDA.

“Beginning November 1 we will take the unprecedented and significant step forward in realizing the key benefits of the Mutual Recognition Agreement with our European counterparts in that we will now rely on the inspectional data obtained by these eight regulatory agencies,”​ Dara Corrigan, FDA acting deputy commissioner for global regulatory operations and policy, said in a statement Tuesday.

Commissioner Scott Gottlieb added through this partnership, FDA “can create greater efficiencies and better fulfil our public health goals, relying on the expertise of our colleagues and refocusing our resources on inspections in higher risk countries.”

Teams from the EU national authorities, the European Commission, EMA and the FDA have been working together since 2014 to assess each other’s auditing procedures.

As part of the collaboration, the EU invited the FDA to observe the internal EU audits of the inspectorates of each Member States performed as part of the Joint Audit Programme (JAP)​. While this week’s announcement sees the FDA recognise eight regulatory agencies’ reports, remaining European inspectorates will continue to be assessed until 15 July 2019.

It also follows an announcement by the EC in June which determined the FDA “has the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU.”

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