Spain

Spain encourages clinical trial sponsors to involve ethics committee in Voluntary Harmonisation Procedure

Eveline Van Keymeulen

On 9 January 2017, the Spanish Agency of Medicinal Products and Medical Devices (AEMPS) issued anĀ information note encouraging clinical trial sponsors to continue using the Voluntary Harmonisation Procedure (VHP) to align with the EU Clinical Trials Regulation (EU) No. 536/2014 (CTR). Once the CTR becomes fully applicable (expected in October 2018), applications for clinical trial Read More