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‘Trade secret information’ to be shared between EMA and FDA

Published on 25/08/17 at 08:51am

As part of the on-going harmonisation of manufacturing standards across the Atlantic, the EMA and FDA have announced that they will now fully share trade secrets relating to medicine inspections.

The process is part of the announcement at the beginning of March that both sides would mutually recognise inspection of drug manufacturing sites made by either body. The EMA noted that the EU and the US had already had a confidentiality arrangement in place since 2003 for sharing information but the new agreement extended the amount of detail that could be exchanged.

In full, the new commitment will lead to the sharing of complete inspection reports of facilities that examined by each agency. It was noted that this would allow for a focus on sites where there was a higher risk. Aside from this benefit, there is the bonus that inspections of various sites will be expedited – as either side can simply follow to the recommendation of whichever agency has reviewed a manufacturing site.

On the signing of the agreement back in March, the EMA explained why the process had begun: “The agreement will enable both the EU authorities and the FDA to make better use of their inspection resources to help them to focus on other parts of the world where active pharmaceutical ingredients (APIs) and medicines for the EU or US markets are manufactured. This will ensure that patients can rely on the quality, safety and efficacy of all medicines, no matter where they have been produced. Around 40% of finished medicines marketed in the EU come from overseas and 80% of the manufacturers of APIs for medicines available in the EU are located outside the Union.”

The next step as part of this process will be for the FDA to sign individual agreements with EU member states’ inspectorates before sharing information with them.

Ben Hargreaves

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