In 1961, an Australian clinician wrote a brief letter to the Lancet to say that he had seen an increased frequency of severe congenital abnormalities in babies born to mothers who had taken thalidomide (Distaval) during pregnancy.1 What followed led not just to a review of the safety of that drug, but sweeping changes to medicines regulation in the UK. Nearly half a century after the establishment of legal regulations on the manufacture, supply, distribution and prescribing of medicines, we celebrate the major impact that one short letter had on drug safety.

This year the Yellow Card Scheme, the United Kingdom's spontaneous pharmacovigilance reporting system, and …