Australian review of policy framework for regulating products at the cosmetic/therapeutic interface
- This consultation closed on 5 May 2005.
- 3 August 2005: Summary of responses to the recommendations (TGA Internet)
On 3 May 2004 involvement was invited in a review of the policy framework for regulating products at the cosmetic / therapeutic interface that is being conducted jointly by the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) and the Non-prescription Medicines Branch of the Therapeutic Goods Administration (TGA).
The review is intended to address the interface issues identified in the Final report and recommendations for NICNAS Low Regulatory Concern Chemicals Reform Initiative as well as separate proposals from the Australian cosmetic industry to the TGA that certain sunscreens should be regulated as cosmetics. Because this examination of the cosmetic/therapeutic interface has implications for the regulatory approach for therapeutic products adopted under the joint trans-Tasman regulatory scheme that will commence operation in mid 2006, the review also examined the regulation of certain therapeutic products under the joint agency.
Following extensive consultation in Australia and New Zealand, the outcome of the review has now been released as a draft discussion paper that will be open for comment before a final report is published. A copy of this document is enclosed and is also available on the TGA, Joint Agency and NICNAS web sites.
In developing options for reform the intention is to undertake an open and consultative process. The closing date for comment was 5 May 2005.
- Review of the regulation of products at the interface between cosmetics and therapeutic goods (pdf, 944kb) *Large file warning
Contents
- Abbreviations
- Acknowledgments
- Terms of reference
- Summary
- Recommendations
- Introduction
- Overview of the regulation of medicines and cosmetics in Australia and New Zealand
- 2.1 Australia
- 2.2 New Zealand
- Overview of the regulation of medicines and cosmetics in other countries
- 3.1 Canada
- 3.2 United Kingdom & the European Union
- 3.3 United States of America
- Regulation of product categories under the joint regulatory scheme for therapeutic products
- 4.1. Antiperspirants
- 4.2. Antidandruff treatments
- 4.3. Sunscreen-containing products
- 4.4 Antibacterial hand washes
- 4.5 Acne washes
- 4.6 Toothpastes and mouthwashes
- 4.7. Other borderline products
- Appendix 1 - Definitions
- Appendix 2 - NICNAS Low Regulatory Concern Chemicals (LRCC) reform
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