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AASLD-FDA-NIH-PhRMA*- Hepatotoxicity Special Interest Group Meeting
2008 Presentations
Drug Induced Liver Injury
International Regulatory Perspectives [PDF] 
Andrew Bartholomaeus, PhD, B.Pharm, MPS
Chief Toxicologist
Therapeutic Goods Administration (TGA), Australia
Abstract
The pharmaceutical industry is a global business with development, clinical trials and sales occurring in multiple countries. Although North America and Europe currently dominate the pharmaceuticals markets, the rapidly growing prosperity of central and eastern Asia and government subsidy of pharmaceuticals in Australia and a number of other countries, create increasingly important markets. Within this global market, both regulators and suppliers are increasingly looking for consistency and standardisation of regulatory guidelines for product development in order to streamline that process and reduce costs associated with marketing approvals. This has been facilitated through the ICH and through international consultations on new guidelines. International collaboration on guideline development has the additional advantage of leveraging global expertise and ensuring that the highest quality science, and broad international experience, is brought to bear on their development.
Australia’s TGA has a policy of not creating guidelines, regulations or other requirements unique to Australia wherever this is possible. This policy is driven both by a recognition that Australia’s market, whilst not insignificant, is relatively small in comparison to that of Europe and the USA providing limited economic leverage, and also by the reality of relatively limited resources available to devote to the independent development of guidelines. The TGA prefers to engage in the development of guidelines on an international level to ensure any unique requirements, related to demographics, climate or the pharmaceutical subsidisation scheme for example, are accommodated within international requirements where necessary. For most technical guidelines few if any unique requirements exist and consequently those of the ICH, EMEA or FDA are formally adopted, and/or routinely referred to, as appropriate. Australia’s engagement with EMEA guidelines is somewhat more formal than with those of the FDA, as the EMEA has acknowledged the TGA as a body to be routinely consulted during the review process for draft guidelines1. In general, Australia routinely considers all EMEA draft guidelines and, following a consultation process with local stakeholders, will make comments or recommendations where appropriate, and subsequently formally consider those guidelines for adoption or non-adoption2.
The use of Guidelines within the TGA is rather more flexible than may be the case in some other jurisdictions. The TGA considers guidelines to be essentially outlines of general principles, thought starters and indicators of best practice. The acceptability of deviations from the guidelines, or use of guidelines from another major jurisdiction, such as those of the FDA, is entirely dependent on the scientific basis and validity of those deviations. There are circumstances however where the guidelines from the EMEA and FDA may differ, the nonclinical study requirements for single dose, first in man, clinical trials for example, which creates some confusion and difficulties for pharmaceutical companies wishing to conduct early phase clinical trials in Australia and elsewhere.
International collaboration on technical guidance has advantages for the pharmaceutical industry, the global regulatory community and ultimately to consumers and providers of pharmaceutical products. The FDA premarket clinical guidance on Drug Induced Liver Injury complements the EMEA guidance on preclinical identification of potential drug induced liver injury3. The TGA welcomes the FDA’s initiative in developing this guidance around an important safety issue.
- eg. Procedure for European Union guidelines and related Documents - available at http://www.emea.europa.eu/pdfs/human/regaffair/2414304en.pdf
- European Guidelines for Prescription Medicines (adopted and not adopted by the TGA) http://www.tga.gov.au/docs/html/euguideh.htm
- Guideline on detection of early signals of drug-induced hepatotoxicity in non-clinical studies.
http://www.emea.europa.eu/pdfs/human/swp/15011506en.pdf
Biography
Andrew Bartholomaeus
Andrew Bartholomaeus, B.Pharm, PhD, MPS, obtained a bachelors degree in pharmacy from the University of Sydney and following professional practice in pharmaceutical manufacturing, hospital and military pharmacy completed a PhD in toxicology at RMIT University in Melbourne. Over the past 15 years Andrew has worked across a broad range of chemical regulatory areas including agricultural, veterinary and industrial chemicals, complementary medicines, and gene technology products. He is currently the Chief Toxicologist with the Therapeutic Goods Administration in Australia with responsibilities primarily in the area of preclinical assessment of prescription medicines and in leading the TGAs response to the Australian National Nanotechnology Strategy. Andrew holds extramural appointments with the University of Canberra, as an Adjunct Professor of Toxicology and Pharmacy, the WHO, as an expert advisor on the toxicology panel, and as a visiting fellow with Inha University in South Korea and the Australian National University in Canberra. He is a member of the Society of Toxicology, the International Society for the Study of Xenobiotics and the Australian Pharmacy Society.
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Date created: April 29, 2008 |
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