You are here

A history of therapeutic goods regulation in Australia

Photo of book: A history of therapeutic goods regulation in AustraliaIn 2007 the TGA commissioned a book outlining the history of therapeutic goods regulation in Australia. The information in the book was researched by Dr John McEwen who has had a long professional association with the TGA.


The TGA today represents the product of a long history of evolution of therapeutic products regulation in Australia. This publication aims to capture this evolutionary process not only as an interesting example of the development and role of a regulator but also to understand the directions for the future.

The book covers the periods from the early 1900s up to 2007.

About the author

Dr John McEwen graduated in pharmacy at the Victorian College of Pharmacy and as a Master of Science in Neurophysiology at Melbourne University. After a period as lecturer in Physiology, he completed medical training and house positions at Royal Melbourne Hospital.

For ten years from 1979, Dr McEwen was Secretary of the Adverse Drug Reactions Advisory Committee and subsequently Head, Drug Evaluation Support Branch. During this time he was a member and later Chairman of the Advisory Board to the WHO Collaborating Centre for International Drug Monitoring based in Uppsala, Sweden and also acted as Editor of Australian Prescriber.

In 1994, Dr McEwen returned to the Therapeutic Goods Administration after five years as Medical Director, CSL Ltd, Melbourne. Dr McEwen became the TGA's Principal Medical Advisor in 2002 and retired from the TGA in 2005.

How to get a copy

How to access a pdf document

*Large file warning: Attempting to open large pdf files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.

This book is available as a free PDF download from this website or as a softcover printed book for $25 including postage within Australia. You can purchase the softcover version by completing a publication order form.

A history of therapeutic goods regulation in Australia (pdf,880kb)*

Further information