What is Pharmacovigilance?


"Pharmacovigilance is the science and set of activities related to the detection, evaluation, understanding and prevention of undesirable effects (or adverse reactions) or any other problem related to safety, in order to improve the safety of the drugs and Public Health. " (Infarmed). This is for the greater purpose of ensuring the protection of public health and making the use of medicines safer and more rational, Pharmacovigilance is a shared responsibility between the various stakeholders:

  • INFARMED / National and International Regulatory Authorities and European Medicines Agency (EMA);
  • Health professionals (doctors, pharmacists, nurses);
  • Pharmaceutical industry;
  • Patients.


The importance of Pharmacovigilance - Safety monitoring


Through continuous and effective monitoring of drug safety, it is possible to inspire and build the confidence of patients and health professionals and of society as a whole. It is therefore essential that the safety of the medicinal product is monitored during the whole life cycle of the medicinal product, not only for the early and effective detection of adverse reactions, but also for complete and improve the safety information of the medicinal product, thus making it possible to detect any new evidence of their safety profile.

Safety signals


A safety signal is a hypothesis supported by data and arguments, which may justify the relationship of the event to the suspected drug. Thus it consists of an alert whose revision or context warrants further investigation. These may arise from a variety of sources of information used in pharmacovigilance throughout the drug cycle in the pre and post-marketing phases.