Consultation: Clinical Trials Schemes Improved Information Sharing
Overview
The Therapeutic Goods Administration (TGA) is seeking feedback on new approaches to information sharing under the clinical trial schemes.
We propose to strengthen the TGA’s ability to release and publish information relevant to the oversight of clinical trials. These proposals are intended to support regulatory decision-making, collaboration between organisations involved in clinical trials, and transparency of regulatory activities.
This consultation seeks your feedback on the potential impact that the proposed changes to information sharing, including the release or publication of information, will have on you or your organisation.
Your feedback will help inform advice to the Australian Government regarding any proposed changes to the regulatory framework governing use of therapeutic goods under the CTN and CTA schemes. In your submission, we ask you to consider and respond to the questions outlined above and to provide any comments on the proposed changes.
Peak bodies are encouraged to provide a single, consolidated submission on behalf of their members, reflecting the collective views of their membership where possible.
Participation and feedback provided during this consultation is greatly appreciated. Following internal review of feedback received, the consultation outcomes will be published on our website. This is expected to occur by early 2027.
Please contact us at clinical.trials@health.gov.au if you have any questions regarding this consultation.
Read the consultation paper
How to respond
To provide feedback, click ‘Submit My Feedback' below.
We invite you to submit feedback through this online platform by close of business 20 November 2026. Email submissions are not required.
Audiences
- Biologicals
- Commonwealth agencies
- Community groups
- Complementary medicines
- Consumers/Public
- General public
- Health professionals
- Health professionals
- Health workforce
- Industry
- Manufacturers
- Manufacturers
- Medical Devices & IVDs
- Medicines
- Non-government organisations
- Other
- Other therapeutic goods
- Over-the-counter medicines
- Prescription medicines
- Sponsors
- Sponsors
- State government agencies
- Unapproved therapeutic goods
Interests
- Clinical trials
- Compliance and enforcement
- Import and export
- Manufacturing
- Pharmacovigilance
- Safety
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