AUSTRALIAN
HOMOEOPATHIC
ASSOCIATION
(NSW Branch)

The 6th Australian Homoeopathic Medicine
Conference 2008

Michelle McLaughlin (TGA)

Michelle McLaughlin, Director, PreMarket Assessment Section,
Office of Complementary Medicines, TGA.

Homœopathic Medicines – A Regulatory Perspective

Abstract
A critical consideration when establishing evidence and efficacy for homœopathic medicine relates to the remedies themselves. A primary mandate of the Australian regulatory system for therapeutic goods is to ensure the quality, safety, efficacy and timely availability of medicines.

Homœopathic medicines are essentially regulated as complementary medicines. Complementary medicines can be designated as low-risk or higher risk, depending upon the ingredient used, the significance of adverse events, the dosage form, the risk of misuse, or the level of promise to the consumer.

This presentation will look at the current and emerging regulatory systems for homœopathic medicines, both in Australia and internationally, and will address what is needed to ensure that a remedy is what it says it is and has been manufactured correctly in accordance with appropriate and recognised standards.

The current evidentiary requirements for marketed homœopathic medicines will be considered, and issues relating to claims and advertising will also be investigated.

The primary aim of the presentation is to raise practitioner awareness of the regulatory requirements that apply to the medicines they use, and how this might impact upon clinical outcomes – whether it be in a practice setting, or in relation to acceptance and applicability of studies that are undertaken.

Biography
Michelle has worked with the Therapeutic Goods Administration since 1993, both as part of the regulatory organisation and as a regulatory affairs consultant. She has been a part of the Office of Complementary Medicines since its inception, specialising in the regulation and evaluation of herbal and homoeopathic. Michelle has a degree in medical laboratory science, and studied naturopathy prior to starting with the TGA. She has considerable experience assessing the impact of regulation on the practice and use of complementary medicines.

The Office of Complementary Medicines is staffed by scientists and practitioners with a wide range of experience and expertise in complementary medicine, including herbal medicine, clinical nutrition and naturopathy. This group is responsible for evaluating and reviewing the safety, quality and efficacy of complementary medicines supplied in Australia.

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