How prescription drugs are developed

Abstract

Modern drug development is a risky business both for pharmaceutical companies and patients. Many thousands of promising compounds need to be tested. Following discovery of a promising compound, extensive animal and human trials are undertaken in consultation with government regulators under strict ethical conditions to provide evidence that the new drug works, is safe and is manufactured using the highest quality standards. This evidence is evaluated by the regulatory authorities and, if acceptable, leads to the registration of the new medicine. Once registered the new medicine may be submitted for government subsidy. In Australia, if the drug demonstrates cost-effectiveness it may become available on the Pharmaceutical Benefits Scheme.