Regulatory arrangements for clinical trials and access to unapproved therapeutic products
- This consultation closed on 8 July 2005.
In April 2003, an independent review of Australian arrangements for clinical trials and access to unapproved therapeutic goods was jointly commissioned by the Therapeutic Goods Administration (TGA) and the National Health and Medical Research Council (NHMRC). This review, which sought input from key stakeholder groups in Australia and New Zealand is now complete.
The review examined current regulatory provisions for clinical trials and access to unapproved therapeutic goods in Australia and internationally. The Terms of Reference outline the issues that were considered and highlight specific topics upon which advice was requested. The report is available in electronic format below, and is open for public comment for a three month period unit Friday, 8 July 2005.
Comments received on the review will be taken into account during the development of the regulatory arrangements for clinical trials and access to unapproved therapeutic products under the joint trans-tasman regulatory scheme.
See below for the Terms of Reference for the review and the Contents of the report.
Contents
- Glossary
- Executive summary
- Chapter 1: Introduction
- Chapter 2: Scope of the Review's deliberations
- Chapter 3: The current situation in Australia and New Zealand
- Chapter 4: Comparison with current avenues of access to unapproved therapeutic goods in the United Kingdom (UK), the United States of America (USA), and Canada
- Chapter 5: Clinical trial notification/exemption
- Chapter 6: Monitoring and audit
- Chapter 7: Ethics committees and scientific assessment
- Chapter 8: Special Access Scheme (SAS) and the Authorised Prescriber Scheme
- Chapter 9: Clinical trials register
- Chapter 10: Infrastructure funding for cooperative groups
- Chapter 11: Trans Tasman joint agency
- Appendices:
- Written submissions made to the Review
- Oral submissions made to the Review
- Workshops on significant issues
- Extracts from the NHMRC "National Statement on Ethical Conduct in Research Involving Humans"
- Relevant Australian and New Zealand legislation
- Reference list
Terms of reference
The Therapeutic Goods Administration and the National Health and Medical Research Council are undertaking a review of the Australian arrangements for clinical trials and access to unapproved therapeutic goods1.
1. where this includes medicines and medical devices
The review will involve consideration of the following:
- existing legislative and regulatory controls for clinical trials, and existing mechanisms relating to access to unapproved therapeutic goods, e.g., special access scheme, authorised prescriber scheme, etc.;
- international practices in comparable countries, e.g., the European Union, Canada, United States;
- the cost of regulation, and the existing fees and charges model for clinical trial notifications/applications in Australia;
- national and international standards relating to consumer protection, and the protection of participants in clinical trials;
- issues relating to public safety and timely access to therapies;
- the ongoing development of a proposal for the establishment of a Trans Tasman regulatory agency, which will result in a single therapeutic goods market between Australia and New Zealand.
The review will require wide consultation with relevant stakeholders including consumers, industry, health professionals, researchers, and human research ethics committees.
The review will examine and advise on:
- the current regulatory systems for clinical trials in Australia and New Zealand;
- the current regulatory systems for access to unapproved therapeutic goods in Australia and New Zealand;
- international practices in comparable countries, and their relevance and applicability to Australia and New Zealand with regard to the volume, scope and safety of clinical research conducted in Australia and New Zealand;
- any necessary improvements to the current system so as to maximise protection of patient safety and to maintain public confidence;
- the need and practicability of a clinical trial register system for Australia, and
- barriers to the further development of clinical research in Australia.
Oversight for the review will be provided by a Steering Committee consisting of relevant Australian and New Zealand representatives, and chaired by the Chief Medical Officer of the Department of Health and Ageing.
The review will be completed by the end of December 2003.
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