Partnering for Success in Spain Pharmacovigilance
If you are a pharmaceutical manufacturer, healthcare provider, or life-sciences organization operating in Spain, access to pharmacovigilance services in Spain is critical to ensuring drug safety and regulatory compliance. From adverse drug reaction reporting to signal detection, risk management planning, safety reporting, and successful market authorisation, the right PV partner shapes everything.
Spanish Regulatory Framework & System
The Division of Pharmacoepidemiology and Pharmacovigilance of the Spanish Agency for Medicines and Medical Devices (AEMPS) oversees all key pharmacovigilance services in Spain. AEMPS is the national authority responsible for ensuring the quality, safety, efficacy, and correct information of medicinal products.
It is supported by the Spanish Pharmacovigilance System for Human Use Medicines (SEFV-H), which is a decentralized system in which regional centres collaborate with AEMPS. The system collects, validates and assesses suspected adverse drug reactions (ADRs). Suspected ADRs are analysed individually and entered into the Farmacovigilancia Española, Datos de Reacciones Adversas (FEDRA) database.
All Marketing Authorisation Holders (MAHs) in Spain must appoint a local contact person for pharmacovigilance, responsible for collecting data on ADRs, implementing risk management plans, and ensuring local pharmacovigilance activities are carried out in compliance with Spanish and European regulations. European pharmacovigilance legislation has increased the volume of information exchanged and received, influencing SEFV-H procedures. AEMPS also ensures alignment with EU good pharmacovigilance practices.
Health Care Pharmacovigilance Solutions & Safety in Spain
DDReg offers healthcare pharmacovigilance solutions that integrate all of the above services, delivering a safety-first culture while fulfilling legal obligations under Spain’s laws (e.g. Royal Decrees and EU regulations) as well as AEMPS and EudraVigilance rules.
Our Pharmacovigilance & Drug Safety Services in Spain Include:
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ICSR Processing & Submission
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Risk Management Plan (RMP)
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Aggregate Reports
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Signal Management
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Qualified Person for Pharmacovigilance (QPPV) Services / Qualified Person (QP)
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PV Audit & Compliance
Our Pharmacovigilance (PV) Services Expertise
ICSR Case Processing and Submission
Our advanced Individual Case Safety Report (ICSR) Pharmacovigilance Services are dedicated to ensuring patient safety through precise case handling....
Literature Monitoring
DDReg’s Literature Monitoring Services offer advanced pharmacovigilance literature screening for drug safety. We help Marketing...
Risk Management
Our expert risk management solutions ensure patient safety by proactively addressing potential hazards in pharmaceutical...
Audit and Compliance
Our specialized services ensure that pharmacovigilance systems across the drug development pipeline meet strict regulatory...
Pharmacovigilance Signal Management Services
DDReg’s specialized pharmacovigilance services ensure that potential adverse events are identified and addressed promptly...
QPPV Services
DDReg’s expert team provides comprehensive QPPV services designed to strengthen your pharmacovigilance system. We ensure that...
