Biologicals

Quick links

Is your product regulated as a biological? Find out how we define a biological and if the regulatory framework for biologicals is relevant to you.

Australian Regulatory Guidelines for Biologicals
Provides information on the supply and use of human cell and tissue-based therapeutic goods, and live animal cells, tissues and organs
Regulatory framework for biologicals
The regulatory framework for biologicals commenced on 31 May 2011. Changes to the regulation of autologous HCT commenced on 1 July 2018
Biological standards
Product-specific and default standards for biologicals
Forms for the biologicals industry
Links to forms for the biologicals industry
Regulatory decisions and notices (biologicals)
Links to regulatory decisions and notices about the regulation of biologicals

If your enquiry is not about biologicals, see: Contact the TGA

Email: bloodandtissues@tga.gov.au

Phone:

Users who are deaf or have a hearing or speech impairment can call through the National Relay Service:

TTY or computer with modem users: phone 1800 555 677 then ask for 1800 678 799
Speak and listen (speech to speech relay) users: phone 1800 555 727 then ask for 1800 678 799

Fax: +61 2 6232 8939

Post: Biological Science Section, Scientific Evaluation Branch, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606, Australia

Street address (for deliveries): Therapeutic Goods Administration, 136 Narrabundah Lane, Symonston ACT 2609, Australia