On 9 January 2017, the Spanish Agency of Medicinal Products and Medical Devices (AEMPS) issued an 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 authorisation involving two or more Member States will follow a coordinated assessment. As the VHP has served as a proof of concept for this coordinated assessment, the AEMPS encourages sponsors to continue using it until the CTR’s application date. Spain has participated in 65% of the clinical trials submitted for VHP assessment since 2009.
Furthermore, the AEMPS “strongly recommends” that sponsors involve an ethics committee (CEIm) in all VHP applications. In this case, Spain’s opinion in the VHP concerning Part I will be binding for both the AEMPS and the CEIm. Once the VHP is completed, sponsors must include a favourable CEIm opinion concerning Part II in any application for clinical trial authorisation or for Part I and II substantial modifications. Sponsors may select a CEIm from a list of accredited ethic committees that is available at the AEMPS website.