What is regulated as a biological?
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
Contact details for biologicals
If your enquiry is not about biologicals, see: Contact the TGA
Email: bloodandtissues@tga.gov.au
Phone:
- 1800 678 799 (freecall within Australia)
- +61 2 6232 8443
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, 27 Scherger Drive, Fairbairn ACT 2609, Australia
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