Regulations in the E.U.
EMA - European Medicines Agency
Established in 2004 the EMA operates as the pharmaceutical and medical device regulatory agency for the European Union.
U.S. - E.U. Safe Harbor
The U.S. and European Union agreement Safe Harbor established privacy and security measures for Protected Health Information being transferred between the U.S. and members of the EU. It bridges the regulatory gaps between regulations in the EU and regulations in the U.S.
