Spanish Agency of Medicines and Medical Devices


The Spanish Agency of Medicines and Medical Devices is a regulatory agency of the Government of Spain that acts as the highest sanitary authority in terms of medical safety on medicines, health products, cosmetics and personal care products.
The agency is responsible for the regulation and authorization of clinical trials and the commercialization of sanitary products for human use, the planification and evaluation of those products along with the European Medicines Agency; the authorization of clinical laboratories, develop the especific rules to ensure the quality of the medical products and inspect all sanitary products of the central government competence. Since 1998, the agency has powers over the control, evaluation and authorization of animal health products.
The agency was created by the Fiscal, Administrative and Social Order Measures Act of 1997 and its powers were extended by another law of the same name from 1998 and by the Cohesion and Quality of the National Health System Act of 2003. It depends directly from the Ministry of Health.
The agency is chaired by a President and a Vice President. Both officials are Under Secretaries of the Ministry of Health and Agriculture. The real chief executive of the agency is the Director.

Organization chart

The agency is divided in six type of bodies: Governing bodies, executive bodies, control committees, administrative bodies, supporting bodies and complementary bodies.