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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.
insights_Blog/mra-on-gmp-facility-inspections.aspx
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.
insights_Blog/new-eu-clinical-trial-regulations-coming--are-you-ready.aspx