Not withstanding FDA’s June 30 announcement that it was delaying enforcement of the Drug Supply Chain Security Act’s next phase by one year (November 2017 to November 2018), the global pharma industry will have invested several billion dollars in hardware and software to comply with that law and related efforts to secure the pharma supply chain around the world.
And while other countries have their own pathway toward providing traceability of pharma shipments, the US’ effort has a small problem: as written, no one knows how the law will work effectively by 2023 when all of its components are to be in place. Oops!
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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 placeExternal link icon to carry out good manufacturing practice (GMP) inspections at a level equivalent to the EU. Today, 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.
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