TGA News Issue 55 (April 2008)
General news
History of therapeutic goods regulation
The TGA recently commissioned a book that outlines 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 period from the early 1900s up to the present.
This book is available as a free PDF download <http://www.tga.gov.au/about/tghistory.htm> or as a softcover printed book for $25 including postage within Australia. You can purchase the softcover version by completing a publications order form <http://www.tga.gov.au/pubs/puborder.htm>.
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, TGA 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 Adviser in 2002 and retired from the TGA in 2005.
NDPSC update
Gazette notices associated with the October 2007 and the February 2008 meetings of the National Drugs and Poisons Schedule Committee and the record of reasons for the October 2007 meeting are available <http://www.tga.gov.au/ndpsc/index.htm>.
Recently updated:
- Scheduling/rescheduling template
<http://www.tga.gov.au/ndpsc/schedule-template.htm> - Guidelines for the National Drugs and Poisons Schedule Committee
<http://www.tga.gov.au/ndpsc/ndpscg.htm> - A guide to labelling drugs and poisons
<http://www.tga.gov.au/ndpsc/gldap.htm> - 2008 NDPSC meeting dates
<http://www.tga.gov.au/ndpsc/meetings.htm>
There is a draft code of practice for national retail storage of Schedule 5 and Schedule 6 products available <http://www.tga.gov.au/ndpsc/drs5s6cop.htm.htm>.
The objective of this document is to provide guidance to manufacturers and retailers on achieving a consistent safety standard for the storage of Schedule 5 and Schedule 6 products in a retail setting that is commensurate with the risk of accidental ingestion by a child.
This Code of Practice provides for an equivalent safety outcome as intended by State and Territory regulations whilst allowing for national consistency in retail storage that meets the expectations of consumers, regulators and other stakeholders, and is commercially feasible.
Recalls
One consumer-level medicine recall has occurred since the last issue of TGA News. <http://www.tga.gov.au/recalls/index.htm
TGC update
As recommended by the TGC at its November 2007 meeting, stakeholder consultation has recently been undertaken on four draft Therapeutic Goods Orders (TGOs) being developed by the TGC. These draft TGOs relate to general requirements for the labelling of medicines, child-resistant packaging requirements for medicines, microbiological standards for medicines and general requirements for tablets and capsules. Stakeholder responses will be considered at the TGC's next meeting in late April 2008.
Now available:
- Summary of key resolutions and meeting report of TGC Meeting 31 (November 2007)
<http://www.tga.gov.au/docs/html/tgc/tgc31.htm> - February 2008 out of session consideration
<http://www.tga.gov.au/docs/html/tgc/tgc0802oos.htm>
TGA website redesign
The TGA website underwent a redesign that went live in December 2007.
There is now an expanded 'browse by audience-type' group. The rest of the site structure remains essentially unchanged. The layout and grouping of the information on pages below the home page have been modified to make it easier to find specific content without having to scroll down a big list of links.