The 1 November marked the operational start of the agreement between the European Union (EU) and the United States (US) to mutually recognise inspections of manufacturing sites for human medicines conducted in their respective territories. Each year, EU national authorities and the US Food and Drug Administration (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. Under the agreement, EU and US regulators will rely on each other's inspections and hence avoid duplication.
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