Pharmacovigilance Green Line: 800 20 28 38

A medicinal product can only be marketed after confirmation of its efficacy, safety and quality, as well as after ensuring the existence of a favorable ratio between the expected benefits and risks.

In addition to the therapeutic benefits that a medicinal product can provide, it can also cause undesirable effects. Therefore, monitoring of the marketed medicinal products safety is a Pharmaceutical Industry responsibility through Pharmacovigilance.

What is Pharmacovigilance?

Pharmacovigilance is defined as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.” (World Health Organization).

Thus, within the scope of Pharmacovigilance, activities of collection, management, analysis and assessment of medicinal products safety information are carried out. According to the benefit/risk ratio of the medicinal product, decisions such as safety alerts, resizing of the packaging dimensions, restrictions on the use of the medicinal product, withdrawal of the medicinal product from the market, etc., are taken.

With the aim of ensuring the protection of public health and making the use of medicinal products safer and more rational, Pharmacovigilance is a responsibility shared between the different players:

  • INFARMED, I.P./National and International Regulatory Authorities;
  • Healthcare professionals (doctors, pharmacists, nurses);
  • Pharmaceutical industry;
  • Patients/Users.

Surveillance does not end with clinical trials…

The clinical trials conducted during the development phase of a medicinal product allow to obtain important information on the medicinal products safety, in particular on their most common undesirable effects and interactions with other medicinal products given simultaneously.

However, this information is limited due to the clinical trials characteristics (participation of a limited number of patients, limited duration of the trial, fixed dose and very strict conditions of use of the medicinal product). These trials do not always reflect the normal conditions of use of a medicinal product.

Therefore, it is essential that during the marketing period of the medicinal product its safety shall be monitored, not only for the effective and early detection of adverse reactions, but also to complete and improve the safety information of that medicinal product.