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Mutual Recognition Agreement on GMP facility Inspections: new framework for the United States and the European Union
The United States and the EU have agreed to amend the Pharmaceutical Annex to the 1998 US-EU Mutual Recognition Agreement (MRA), allowing the US and the EU to utilize each other's good manufacturing practice (GMP) inspections of pharmaceutical manufacturing facilities.
New EU Clinical Trial Regulations Coming. Are You Ready?
In March of 2016, regulators within the European Union (EU) have approved a new clinical trial initiative designed to quicken the approval process for promising new drugs that address medical needs that are otherwise currently unmet.