Background    
Pharmacovigilance is defined by the World Health Organization (WHO) as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems.  Pharmacovigilance developed as a result of the Thalidomide disaster in 1961 when thousands of congenitally deformed infants were born after exposure to Thalidomide  in utero.  At that time Thalidomide  was widely prescribed for pregnant women to treat nausea associated with morning sickness.

In 1963 as a consequence of the Thalidomide tragedy, the 16th World Health Assembly adopted a resolution (16.36) that reaffirmed the need for early action in regard to rapid dissemination of information on adverse drug reactions (ADRs).  The resolution invited member states to arrange for a systematic collection of information on serious adverse drug reactions observed during the development of a medicine and, in particular, after its release for public use.  The WHO Programme for International Drug Monitoring (PIDM) initially started in 1968 with 10 member countries but now (as of November 1, 2023) boasts a membership of 178 countries (156 full members & 22 associate members) .  The WHO PIDM is coordinated by the WHO Collaborating Centre for International Drug Monitoring - the Uppsala Monitoring Centre (UMC) in Sweden.