US and EU Sign Agreement to Mutually Recognize Drug Manufacturing Inspections

In 1998, the European Union (EU) and the US signed the Mutual Recognition Agreement (MRA) with provisions specifically about current Good Manufacturing Practices (cGMPs) for drugs but were unable to start implementation. Since 2014, both the US and European Medicines Agency (EMA) revived agreement talks concerning the cGMP provisions. Starting in 2012 with the passage[…]

UK Pharma Industry Bracing for Possible Disruption

From FierceBiotech: GlaxoSmithKline CEO Andrew Witty fears that if the European Medicines Agency (EMA) is moved from London, it will cause a tremendous disruption for the UK’s pharma and biotech industry. Experts worry about the possibility of regulatory upheaval if Brexit happens. The fate of the EMA is in the air. Brexit is currently in[…]