20
Feb
This article is courtesy of Anthia Zammit Legal, a member of the EACCNY.
At present date, there is no Mutual Recognition Agreement (MRA) in relation to:
• conformity assessment of regulated products, and
• Good Manufacturing Practice (GMP)
for human and veterinary medicinal products in operation between the EU and the US.
On November 14th and 17th 2014, representatives of the US FDA met with a cross-agency team from the European Medicines Agency (EMA), the European Commission, and Good Manufacturing Practice (GMP) experts from...