AEMPS (Agencia Española de Medicamentos y Productos Sanitarios)

The AEMPS is a public body which belongs to the Spanish Ministry of Health. Its mission is to give guarantees to the general public on the quality, safety, efficacy and accurate information on medicines and medical devices from research to end use, to protect and promote health in both humans and animals.

The AEMPS develops a wide range of activities within the framework of medicine evaluation and authorization for human and animal use: clinical trials authorization, continuous monitoring of medicine safety once medicines go on the market, quality control, authorization and inspection of pharmaceutical laboratories, supervision of medicine supplies, certification, control and supervision of medical devices, combating illegal and counterfeit medicines and medical devices, monitoring safety procedures for cosmetics and hygiene products, and providing all relevant information to the public and health care professionals.

The AEMPS shares information on serious adverse reactions with the European Medicines Agency and other EU medicines agencies. The objective of the AEMPS is to detect them as early as possible, before and after marketing and sale, to arrive at an accurate assessment of the benefits and risks at all times.
Regarding pharmacovigilance, the AEMPS has developed and currently maintains BIFAP, a longitudinal population-based database of anonymized computer based medical records of general practitioners (GPs) throughout Spain, to perform pharmacoepidemiological studies. BIFAP currently contains clinical records from more than 3 million patients.
In relation to SAFEGUARD, AEMPS will collaborate mostly in WP4 by exploiting the BIFAP database for observational studies.

Website: www.aemps.gob.es

Team members:

  • Dolores Montero
  • Miguel Gil
  • Ana Afonso
  • Francisco de Abajo
  • José Luis Alonso-Lebrero

Contact email: dmontero@aemps.es