Introduction

The Spanish Agency for Medicines and Health Products (AEMPS) has published the annual report of the Spanish Pharmacovigilance System for Medicines for Human Use (SEFV-H), highlighting key developments in drug safety pharmacovigilance and adverse drug reaction monitoring during 2025.

Pharmacovigilance systems play a critical role in detecting, assessing, and preventing medicine-related risks. The latest report reflects increased reporting activity, strengthened safety signal detection, and ongoing improvements in pharmacovigilance practices.

Increase in Adverse Drug Reaction Reporting

In 2025, a total of 40,990 reports of suspected adverse drug reactions were recorded, representing an 8.9% increase compared to the previous year.

Among these reports:

• 48.7% were submitted directly to the SEFV-H
• 32.2% were classified as serious cases

The overall reporting rate reached 41 cases per 100,000 inhabitants, highlighting the growing importance of ICSR pharmacovigilance in supporting drug safety and pharmacovigilance systems.

Most Frequently Reported Adverse Reactions

The report confirms that the most commonly reported suspected adverse reactions remained consistent with previous years, mainly involving:

• Gastrointestinal disorders
• Skin and subcutaneous tissue disorders
• Nervous system disorders

These findings support ongoing safety signal detection in pharmacovigilance and reinforce the importance of continuous monitoring and evaluation of safety signals.

Strengthening Signal Detection and Reporting Systems

During 2025, the SEFV-H published several key documents to improve pharmacovigilance processes and standardization:

• A user manual for the NotificaRAM electronic reporting system
• A SEFV-H coding guide for suspected adverse reactions
• A SEFV-H signal detection guide describing methodologies for identifying new risks.

These initiatives aim to enhance literature monitoring in pharmacovigilance, improve data quality, and strengthen signal detection pharmacovigilance activities.

Structured pharmacovigilance services and standardized procedures are essential to ensure accurate data collection, effective analysis, and regulatory compliance across pharmacovigilance systems.

Organizations supporting these processes through pharmacovigilance consulting services and pharmacovigilance solutions contribute significantly to improving reporting quality and safety signal detection.

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Encouraging Public and Healthcare Professional Reporting

AEMPS emphasized the importance of reporting suspected adverse drug reactions through regional pharmacovigilance centers or via the NotificaRAM electronic platform.

Increased participation from healthcare professionals and the public supports:

• Early detection of safety signals
• Improved aggregate report analysis
• Stronger drug safety pharmacovigilance systems

Continuous reporting plays a key role in identifying new or changing risks and ensuring effective regulatory decision-making.

Conclusion

The 2025 annual report highlights the growing role of pharmacovigilance in Spain, with increased reporting rates and strengthened safety monitoring frameworks.

Through enhanced signal detection, improved reporting tools, and continued collaboration, pharmacovigilance systems remain essential in protecting public health and ensuring the safe use of medicines.

For more information: The Spanish Agency for Medicines and Health Products (AEMPS) publishes the Annual Report of the Spanish Pharmacovigilance System for Medicines for Human Use