TGA Office of Complementary Medicines
Staff and structure
The Office of Complementary Medicines (OCM) consists of three functional groups:
- the PreMarket Assessment Section;
- the Listed Medicines and Communications Section; and
- the Post Market Review Section.
The staff of the OCM have a wide range of experience and expertise in the regulation of complementary medicines, including toxicology, herbal medicine, nutrition, naturopathy, microbiology and natural product chemistry.
Prof David Briggs, Director of the Office of Complementary Medicines
David Briggs is Director of the Office of Complementary Medicines in the Therapeutic Goods Administration in Canberra. Before taking up his position in the Office of Complementary Medicines, David was Professor and Head of the School of Nutrition and Public Health at Deakin University in Victoria. He has an MSc from the University of Melbourne and a PhD from The School of Pharmacy, University of London. His particular interests have been in the chemistry of natural products and nutrition and he has published many scientific papers, articles and texts in these areas. He has previously worked in a regulatory environment as principal science advisor to the Australia New Zealand Food Authority (now Food Standards Australia New Zealand) and also in the Division of Toxicology Research, Bureau of Chemical Safety in Health Canada.
Professor Briggs is an Adjunct Professor in the Centre for Complementary Medicine Research at the University of Western Sydney. He is also currently a Member of the International Advisory Board on Hong Kong Chinese Materia Medica Standards, the Standing Committee of the Western Pacific Regional Forum for the Harmonization of Herbal Medicines and is a WHO Temporary Adviser for the development of monographs for herbal medicines.
Ms Michelle McLaughlin, Manager of the PreMarket Assessment Section
Ms Michelle McLaughlin is the Manager of the PreMarket Assessment Section. Michelle holds a Bachelor of Applied Science in Medical Laboratory Science, and has also studied naturopathy. Prior to starting with the TGA, Michelle worked with the Red Cross Blood Bank of Victoria, both as a medical scientist and a regulatory compliance officer. Michelle has worked in the regulatory environment since 1993, both with TGA and as a regulatory affairs consultant. She has been a part of the Office of Complementary Medicines since its inception, and has specialised in the regulation and evaluation of herbal and homoeopathic medicines.
The PreMarket Assessment Section is staffed by scientists including toxicologists, with a wide range of experience and expertise in complementary medicine, including herbal medicine, clinical nutrition and naturopathy. This group is responsible for:
- evaluating the quality and safety of new substances for use in Listable medicines;
- reviewing the safety and efficacy of products for Registration;
- reviewing evidence to support indications and claims for complementary medicines in response to complaints, or where there are safety concerns or the indications/claims appear to be wilfully misleading; and
- reviewing the safety of Listable substances or Listed or Registered complementary medicines where adverse reactions or other problems arise.
For information or enquiries related to evaluation and review, please phone 1800 020 653.
Ms Libby Kerr, Manager of the Listed Medicines and Communications Section
Ms Libby Kerr is Manager of the Listed Medicines and Communications Section. Libby has a Bachelor of Science (Hons) in Biochemistry and Pharmacology and a Masters of Applied Science in Biopharmaceuticals. Prior to joining the TGA in 1999, Libby worked in a variety of medical research areas. Since joining the TGA, Libby has worked in several areas in the Drug Safety and Evaluation Branch, and was also the OCM's Parliamentary Liaison and Communications Officer for three years. After working with the Ministerial Council on Drug Strategy and Intergovernmental Committee on Drugs for 18 months she returned to the OCM in March 2008.
The Listed Medicines and Communications Section is responsible for:
- maintenance and support of the Electronic Listing Facility (ELF);
- provision of advice and assistance to sponsors, consultants and the general public regarding the Listing of complementary medicines;
- preparation of briefings for the Minister, responses to correspondence to the Minister and other Parliamentary documents related to complementary medicines;
- management and coordination of stakeholder consultations regarding complementary medicines;
- maintenance of information on the TGA website related to complementary medicines; and
- management of other projects specific to complementary medicines, for example, the Australian Regulatory Guidelines for Complementary Medicines (ARGCM).
Mr Michael Wiseman, Manager of Post Market Review Section
Mr Michael Wiseman is Manager of the Post Market Review Section. Michael has a Bachelor of Applied Science in Medical Laboratory Science. Prior to joining the OCM, Michael worked in the Microbiology Section of the TGA Laboratories. Prior to joining the TGA in 1997, Michael worked in the pathology laboratory of Canberra Hospital.
The Post Market Review Section is responsible for:
- monitoring of medicines Listed on the ARTG through the Electronic Listing Facility (ELF);
- investigation of complementary medicines where a potential problem has been identified, for example suspected adverse reactions;
- targeted and random reviews of the safety and efficacy of complementary medicines; and
- regulatory action in relation to complementary medicines.
Dr Bogdan Sikorski, Manager, Technical and Permitted Ingredients List Project
Dr Bogdan Sikorski is the technical manager in the Pre-Market Assessment Section, and the manager of the Permitted Ingredients List (PIL) Project. Bogdan majored in pharmacology (BSc Hons) and, for his PhD project, investigated aspects of changes in vascular responsiveness in experimental model of diabetes at the Monash University (Melbourne). Following a short stint as a research assistant at the Department of Pharmacology at Monash University, and a few years running family business, Bogdan obtained a Graduate Diploma in Occupational and Environmental Health, Department of Epidemiology and Preventive Medicine at Monash University, before starting at the TGA as a toxicology evaluator in the Drug Safety and Evaluation Branch. In 2001, Bogdan joined the OCM as a senior toxicologist, and in 2004 was promoted to the manager of the PIL Project.
In the capacity as the technical manager, Bogdan is working across the Pre-Market Assessment and Post-Market Review Sections, overseeing and assisting in:
- evaluation of quality and safety of new ingredients for use in Listed medicines;
- evaluation of quality, safety and efficacy of complementary medicine products for Registration;
- review of safety of complementary medicine products/ingredients where a potential problem has been identified; and
- regulatory actions in relation to complementary medicines, including development of Compositional Guidelines (Monographs).
As the manager of the PIL Project, Bogdan has been leading the team of evaluators (from both TGA and Medsafe) evaluating quality and safety of new ingredients for use in Class 1 medicines, as part of the move to a Joint Australian New Zealand therapeutic products regulatory system.