Gateway to the largest biotechnology sector in Australia

Find

Victorian Platform Technologies

Find Infrastructure

What's this

Victorian Biotech Companies & Providers

Advanced Search
What's this

Registration and Approval

Registration

Clinical Trials involving therapeutic goods are regulated by the Therapeutic Goods Administration, which is part of the Federal government portfolio of Health and Ageing.

There are two schemes under which clinical trials involving therapeutic goods may be conducted in Australia: the Clinical Trial Exemption (CTX) Scheme and the Clinical Trial Notification (CTN) Scheme.

The Therapeutic Goods Administration website provides an outline of the two registration schemes, and of the situations in which each scheme applies.

Approval

CTN Scheme

The CTN Scheme is a notification scheme and, as such, no TGA approval is given. While it is advisable for sponsors to wait for the TGA's acknowledgment letter before commencing the trial, this is not a legal requirement. For more information about this process, click here

Human Research Ethics Committees (HRECs)

All Australian clinical trials which use therapeutic goods that require an exemption under the Therapeutic Goods Act 1989 must be approved by ethics committees. Only ethics committees that operate in accordance with the NHMRC's National Statement on Ethical Conduct in Research Involving Humans are allowed to approve such trials. Further information about this process can be found on the FAQ section of the TGA website.  A copy of the Human Research Ethics Committee legislation is also available on the TGA website.

What's Happening?

8th May BioBreakfast - The Technological and Economic Opportunities of BioBanking in Australia

Tuesday 8th May, 7:15am - 9:00am
Cinema 1, Australian Centre for the Moving Image (ACMI), Federation Square, Melbourne

As the pharmaceutical industry and the wider research sector shifts rapidly towards personalised medicine and genomics combined with the increasing power of computational sciences, biobanking is clearly an emerging winner in terms of commercialisation opportunity and provision of quality research services for the future.

More news and events