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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Softbank, the Japanese telecommunications giant, has been on a multibillion-dollar acquisition and investment spree for the past year or so. It isn’t over. Today the pharmaceutical company Roivant is announcing a $1.1 billion investment, mostly from the SoftBank Vision Fund. It’s perhaps the largest single biotech investment ever. And after the biggest biotech IPOs of 2015 and 2016, this new money might also be another validation of Roivant’s development approach, grabbing up promising-but-abandoned drug candidates that other companies couldn’t get across the finish line. Click here for more…