EU-US mutual recognition of inspections enters operational phase

The agreement covering the inspection of drug manufacturers enables both the EU authorities and the FDA to make better use of resources

1 November 2017 marks the operational start of the mutual agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories.

Each year, EU national authorities and the FDA inspect many manufacturing sites of medicinal products in the EU, the US and elsewhere in the world, to ensure that these sites operate in compliance with good manufacturing practice (GMP). Under the agreement, EU and US regulators will rely on each other’s inspections and hence avoid duplication.

The European Medicines Agency (EMA) says that in June, the European Commission confirmed that the US Food and Drug Administration (FDA) has the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU.

The FDA has now confirmed the capability of eight EU Member States (Austria, Croatia, France, Italy, Malta, Spain, Sweden, and United Kingdom). The remaining inspectorates will continue to be assessed until 15 July 2019.

This is unprecedented as the FDA has never before recognised another country’s inspectorate. It is also a major milestone towards closer cooperation to improve the use of available resources to safeguard quality and safety of medicines. This addresses the fact that for around 85% of medicines sold in the EU, at least one manufacturing step takes place outside the Union.

Professor Guido Rasi, Executive Director of the EMA said: “We need to think globally and work strategically with partners from around the world to make best use of our inspection capacity, so that patients can rely on the quality, safety and efficacy of all medicines, no matter where they have been manufactured.”

He added: "I am very pleased that we can now add the mutual recognition agreement with the FDA to our six existing agreements with third-country authorities. It is a testimony to the trust that exists between our regions and that has grown over many years of cooperation for the sake of patients on both sides of the Atlantic.”

The agreement enables both the EU authorities and the FDA to make better use of their inspection resources and focus on sites of higher risk where active pharmaceutical ingredients and medicines for the EU or US markets are manufactured. Around 40% of finished medicines marketed in the EU come from overseas and 80% of the manufacturers of active pharmaceutical ingredients for medicines available in the EU are located outside the Union.

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