Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) is Spain’s national regulatory authority responsible for medicines, medical devices, and clinical trial oversight.
AEMPS reviews clinical trial applications, monitors safety reporting, and enforces compliance within Spain. Its requirements align with European Union regulations and Good Clinical Practice standards. Sponsors conducting multinational studies must coordinate submissions and safety communications with AEMPS. Regulatory alignment supports smooth authorization and ongoing oversight.