Prescription Products
This article was originally published in SRA
Executive Summary
Regulations outlined in on-line summary
Regulations outlined in on-line summary
The Australian Therapeutic Goods Administration (TGA) has posted on its website an outline of the regulation of prescription medicinal products in Australia, together with a history of the Australian Drug Evaluation Committee (ADEC)1. The document describes the evaluation process and likely timeframes, together with the role of ADEC and its sub-committees. A brief explanation of various exemptions such as clinical trials and special access schemes is also provided, and an outline of the post-market activities conducted by the TGA. These documents are easy to read and provide a good introduction to the practices in Australia as well as guidance on where to go for further information.
CARMEN LANGLEY
References
1. Australian Regulation of Prescription Medical Products, August 2003, www.tga.gov.au/docs/html/pmeds_reg.htm