TGA report on information and advertising associated with products tested, created or manufactured using human embryos or human embryonic stem cells
September 2003
On 12 May 2003, Senator Harradine wrote to Senator Kay Patterson, Minister for Health and Ageing (the Minister) notifying that he intended to move amendments to the Therapeutic Goods Amendment Bill (No.2) 2002.
The Minister undertook to review the issue and consult with industry, tabling a Report in the Senate. This Report is in response to the Minister's commitment.
This Report has been prepared following consultations with the key medicines and device industry associations, with scientists who have specialist knowledge of embryonic stem cell research, and with scientists and medical experts in evaluation and regulation of therapeutic goods within the Therapeutic Goods Administration. Relevant literature has also been reviewed.
Contents
- Part 1: Introduction
- Part 2: Contextual information about the operation of the Therapeutic Goods Act 1989
- Part 3: Contextual information about the use of human embryos and human embryonic stem cells in Australia
- Part 4: Organisations and individuals consulted to inform this Report
- Part 5: Issues arising as a result of consultations and research
- Part 6: Summary
- Part 7: Recommendation
- Attachment A - Amendments proposed by Senator Harradine
- Attachment B - Proposed approach to amendments to the Therapeutic Goods Regulations 1990