Pharmacovigilance —understood as the set of activities aimed at identifying, quantifying, assessing and preventing adverse reactions to medicines— represents a strategic pillar in the lifecycle of every medicinal product, ensuring its safety and efficacy on an ongoing basis. It is also a shared responsibility between public authorities, the pharmaceutical industry, healthcare professionals and patients, as coordinated action by all these parties enables a comprehensive picture of each medicinal product’s safety profile to be established.
In recent years, pharmaceutical companies have become increasingly aware of the value of rigorous management of suspected adverse drug reactions (“ADRs”), as well as the importance of strengthening communication and collaboration with the relevant health authorities, particularly the Spanish Agency for Medicines and Health Products (“AEMPS”, the Spanish acronym for Agencia Española de Medicamentos y Productos Sanitarios).
In this context, Farmaindustria, together with AEMPS and associated companies, has drawn up the document Recomendaciones para una mejora en la recogida de datos de farmacovigilancia en España, which aims to move towards a more open, participatory and sustainable pharmacovigilance model. The initiative highlights that the early detection of safety signals depends fundamentally on the quality of the relevant information gathered through adverse reaction reports. Achieving this standard of quality, in turn, requires collaboration between the AEMPS, the pharmaceutical industry, healthcare professionals and patients.
The recommendations, which emerged from a collaborative workshop held in 2025 to analyse the collection of information on adverse drug reaction reports, are structured around four key areas:
- Education and awareness-raising, through the promotion of training programmes aimed at healthcare professionals and patients, the inclusion of pharmacovigilance content in university health sciences curricula, and the development of regular public information campaigns on the importance of comprehensive reporting of ADRs.
- Institutional and scientific collaboration, fostering ongoing dialogue between the AEMPS, regional pharmacovigilance centres and the pharmaceutical industry, promoting the signing of agreements with scientific societies and professional bodies, and strengthening joint work with authors of publications describing relevant cases.
- Internal collaboration within pharmaceutical companies, optimising coordination between pharmacovigilance departments and other internal areas, and strengthening the continuous training of staff.
- Technological innovation and support tools, including the development of smart forms, the implementation of multi-device digital platforms and the incorporation of automatic reminders to complete critical information.
In conclusion, the implementation of these recommendations will help to consolidate a more robust and efficient pharmacovigilance system in Spain, in which collaboration between all stakeholders —public authorities, the pharmaceutical industry, healthcare professionals and patients— is essential to ensuring the safety of medicines and protecting public health.
For further information, please do not hesitate to contact our specialists at Cuatrecasas via the Knowledge and Innovation Department.
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