A product for which therapeutic claims are made must be listed, registered or included in the Australian Register of Therapeutic Goods before it can be marketed in Australia. The drug regulatory approval process is complex and resource-intensive. It must be accountable in terms of the quality, safety and efficacy of drugs. This accountability includes an acceptance of a balance between safety and efficacy. There is no such thing as a totally safe drug, and the approval process must recognise the risk/benefit ratio, of any particular drug. V. Yugender Reddy, M. P. Venkatesh, T. M. Pramod Kumar of JSS College of Pharmacy, JSS University, Mysore, focuses on the regulatory requirements and submission process for prescription generic drugs in Australia.