Report for TGA on 'Cell, Gene and Tissue Regulatory Framework in Australia: Stakeholder Perspectives' Published
15 July 2022
In November 2021, the Therapeutic Goods Administration (TGA) commissioned MTPConnect to conduct a stakeholder review of the regulatory framework for gene, cell and tissue therapies in Australia.
Working with Evohealth, MTPConnect's review involved individual interviews and group sessions with key stakeholders from across the sector, including from:
- Pharmaceutical and biotechnology industry
- Clinical trials
- Regulatory
- Clinicians
- Researchers
- Ethics committee
- Manufacturing
- Patient advocacy/consumer groups.
The full report has now been published, including MTPConnect's major findings and the TGA's proposed response to the major recommendations.