Pharmacovigilance services in Spain

The Division of Pharmacoepidemiology and Pharmacovigilance of the Spanish Agency on Medicines and Medical Devices (AEMPS) oversees all key pharmacovigilance services. It is supported by the robust Spanish Pharmacovigilance System which is a decentralized system that collects and assesses suspected ADRs. All domestic national are analyzed individually and entered into the Pharmacovigilance Espanola-Datos de Reaction adversas (FEDRA) database. All MAHs must appoint a local contact person for pharmacovigilance who would be responsible for collecting data on ADRs, implementing risk management plans, and for making sure local pharmacovigilance activities are being carried out compliantly in Spain. The European legislation has had a clear impact on the amount of information received and exchanged, which is obviously influencing the procedures of the Spanish Pharmacovigilance System. The enormous effort toward risk identification that Europe is performing should be followed, from the perspective of the Pharmacovigilance Unit, by establishing communication networks to improve the overall accuracy in estimating risks.

As a leading global contender, DDReg understands the significance of patient safety right from spontaneous to post-marketing surveillance of medicinal products. As part of our safety services portfolio, we provide end-to-end pharmacovigilance services in Spain that include adverse drug reaction reporting, signal detection & management, aggregate report writing, development of customized pharmacovigilance plans/risk management plans in accordance with the local requirements and good pharmacovigilance practices.