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EU-US reach landmark deal on mutual recognition of manufacturing inspection

Published on 03/03/17 at 10:25am

The European Union and the US has announced that an agreement has been made to mutually recognise inspection of drug manufacturing sites on both sides of the Atlantic. The deal will see reduced costs for both unions, as there will now be no need to repeat and duplicate inspections.

The agreement has been mooted for a long time, once discussions began on the Transatlantic Trade and Investment Partnership began under President Obama’s administration. Though this deal now looks in jeopardy after President Trump scrapped the Trans-Pacific Partnership and halted further discussions, the mutual recognition of manufacturing inspection has made it through with common sense reasons for both sides to maintain it.

The mutual recognition of good manufacturing practice will allow both sides to save money, with an estimated saving of approximately $1 billion in regulatory costs for the US. The EMA has suggested that any money saved could then be redirected to ensuring more extensive inspection of sites in other areas of the world.

The EMA explained this reasoning in a press release: “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 mutual recognition expands the EU’s current deals with Switzerland, Australia, New Zealand, Japan, Canada and Israel.

“The Mutual Recognition Agreement is an important step in working collaboratively and strategically with key partners to help ensure that American patients have access to safe, effective and high quality drugs,” said Dara Corrigan, FDA’s associate commissioner for global regulatory policy.

The FDA had been working collaboratively with the EMA, as part of the EU’s Joint Audit Programme, to ensure that standards of inspection were sufficient. The process involves two EU nations auditing the regulatory authority of another EU country in an on-going process since May 2014.

Ben Hargreaves

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