Regulatory Services in Spain

The Spanish Agency for Medicines and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS), under the Ministry of Health, holds exclusive authority over the approval, licensing, and ongoing monitoring of the safety, efficacy, quality, and compliance of pharmaceutical and medicinal products in Spain. The AEMPS plays a pivotal role in regulating and authorizing clinical trials in accordance with the guidelines set by the European Medicines Agency (EMA). This regulatory body provides comprehensive guidelines covering the registration process, pharmacovigilance services, clinical trials, product availability, formulations, packaging, and labeling requirements for medicinal products intended for human use. These guidelines are continually reviewed and updated to stay aligned with European regulations.

Furthermore, the AEMPS is authorized to share non-public information with the U.S. FDA for pre-marketing and post-marketing activities regarding AEMPS-regulated drugs. This ensures that all pharmaceutical and veterinary products undergo rigorous evaluation, authorization, monitoring, and supervision to ensure they remain compliant with Spain’s regional and European guidelines. Manufacturers seeking successful market authorizations for their products in Spain must remain fully informed about all the regulatory requirements set by AEMPS.