Prescription Drug Approval Process: Australia

In 1991, Peter Baume, professor and former health minister, was appointed to write a report on the future of drug evaluation in Australia. This assignment was made because of a public dissatisfaction with the pharmaceutical approval system. This 232-page document pointed out flaws in the prescription drug approval process of that period, and made recommendations for change. All of his recommendations were implemented, putting into place the prescription drug approval process active today (October 2014).

Timeliness of recommendations by the Therapeutic Goods Administration (TGA) and timeliness of future drug availability were key issues addressed by Baume. Baume also recommended that Australia’s drug evaluation process be made in close conformity with that of the European community; in this way, identical data can be submitted simultaneous to Australia ...