The Australian Medicines Regulatory System: A Risk-Based Approach to Regulation

摘要

The system of medicine regulation in Australia developed in response to public health needs. It began with the decision to test for the quality of medicines that were considered necessary to ensure public health and that were therefore subsidized by the Australian government in the 1950s.In 1961 an Australian obstetrician, Dr. William McBride, published his observation of birth defects in association with the use of the medicine thalidomide in a letter to the Lancet. Thalido-mide had been used in the management of nausea in pregnancy but its use was indeed associated with characteristic and devastating congenital abnormalities. This episode highlighted that assurance of quality in itself, while of great importance, was not sufficient to prevent tragedies from occurring.