It was not until the disaster caused by thalidomide in 1961 that the first systematic international efforts were initiated to address drug safety issues. From these beginnings emerged the practice and science of pharmacovigilance.

According to WHO, pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. Essentially, it is drug safety.

The specific aims of pharmacovigilance are to:

               - improve patient care and safety in relation to the use of medicines and all medical and

               - paramedical interventions,

               - improve public health and safety in relation to the use of medicines,

               - contribute to the assessment of benefit, harm, effectiveness and risk of medicines,

               - encouraging their safe, rational and more effective (including cost-effective) use, and

               - promote understanding, education and clinical training in pharmacovigilance and its

               - effective communication to the public.

Before a medicine is authorised for use, evidence of its safety and efficacy is limited to the results from clinical trials, where patients are selected carefully and followed up very closely under controlled conditions. This means that at the time of a medicine's authorisation, it has been tested in a relatively small number of selected patients for a limited length of time.

After authorisation the medicine may be used in a large number of patients, for a long period of time and with other medicines. Certain side effects may emerge in such circumstances.

It is therefore essential that the safety of all medicines is monitored throughout their use in healthcare practice.

EU law, therefore, requires each marketing authorisation holder, national competent authority and EMA to operate a pharmacovigilance system.

A pharmacovigilance system is defined as a system used by an organisation to fulfil its legal tasks and responsibilities in relation to pharmacovigilance and designed to monitor the safety of authorized medicinal products and detect any change to their risk-benefit balance.

The pharmacovigilance system in EU must comply with the approved Good Pharmacovigilance Practices (GVPs), as well as the applicable legislation in force.


Reference: The importance of Pharmacovigilance. Safety Monitoring of medicinal products. World Health Organization 2002; European Medicines Agency: Pharmacovigilance Overview and Good Pharmacovigilance Practices.

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