EU and US set to take regulatory relationship further
This article was originally published in RAJ Devices
Executive Summary
The EU and US medicines agencies are set to renew and intensify their co-operation in the field of medicines regulation. Meeting in London on 30 September and 1 October this year, the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) agreed that the confidentiality arrangements that have already been in place for five years, have been a resounding success, thereby encouraging them to expand their collaboration in existing as well as new areas, including advanced therapy medicines, nanotechnology-derived medicinal products and the exchange of pharmacovigilance information.