Spanish Approval Process

Clinical trials in Spain are regulated in accordance with the Royal Decree 1090/2015, and the Regulation (UE) No 536/2014 of the European Parliament and of the Council. The initiation of a clinical trial in Spain requires two key approvals: by an authorized Ethics Committee and by the national regulatory authority, the Spanish Agency of Medicines and Medical Devices (AEMPS).

Clinical trial start-up time: 5 – 6 months.

Spanish Pre-Market Approval

In order to capitalize on the vast potential of clinical trials in Spain it is imperative to stay on top of the necessary meeting dates with the Ethics Committees tied to the clinical sites chosen, as well as the urgency to produce the required Dossier within the 1st day of the corresponding month. The essential documents cover a wide range or information as well as specific documents that are compliant to Organic Law to 15/1999 and a Declaration for invoicing for the evaluation of study documents by the Spanish Authorities.

There is also the strict adherence to AEMPS Timelines, which changes the necessary requirements depending on the medical device’s class.

Investigators and Sites

Spain a key player in research and development at the European and global levels and an innovation and knowledge hub with research centers of excellence. Over the past few years, Spain has been specializing in clinical research so that nowadays many hospitals own a research unit for clinical trials to ensure high- quality research both in terms of data and patients’ safety.