1 November 2017 marks the coming into operation of further aspects of the mutual recognition 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. This agreement, which updates the agreement from 1998, allows for recognition of each other’s inspection outcomes and hence for better use of inspection expertise and resources.
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 good manufacturing practice (GMP) inspections at a level equivalent to the EU. On 31st of October 2017, the FDA 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.
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 GMP. Under the mutual recognition agreement, EU and US regulators will rely on each other’s inspections and hence avoid duplication.
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.
Please refer to the full publication available on EMA website here.