Regulation of blood & tissues
Blood, blood components, plasma derivatives, tissue and cellular products, and tissue and cell based derivatives are regulated under the Therapeutic Goods Act 1989.
If you have an enquiry about the regulation of blood & tissues that is not answered by this website, please see the contact details below.
Blood & tissues
- Regulation of blood
<http://www.tga.gov.au/bt/blood.htm>- TGO 74 Standards for blood components
<http://www.tga.gov.au/docs/html/tgo/tgo74.htm> - Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2007
- TGO 74 Standards for blood components
- Regulation of tissues
<http://www.tga.gov.au/bt/tissues.htm>- Proposed regulatory framework for tissues and emerging biological therapies
<http://www.tga.gov.au/prtisreg.htm>
- Proposed regulatory framework for tissues and emerging biological therapies
- Facility registration
<http://www.tga.gov.au/facilityreg.htm> - Forms
<http://www.tga.gov.au/forms.htm> - Australian code of good manufacturing practice - human blood and tissues
<http://www.tga.gov.au/manuf/gmpbltic.htm> - Technical Master Files for blood, blood components and haematopoietic progenitor cells
<http://www.tga.gov.au/manuf/tmf_blood.htm>
Haematopoietic progenitor cells (HPCs)
- Status of the regulatory oversight of haematopoietic progenitor cells (HPCs)
<http://www.tga.gov.au/bt/hpcs.htm> - TGO 75 Standards for haematopoietic progenitor cells derived from cord blood
<http://www.tga.gov.au/docs/html/tgo/tgo75.htm> - Technical Master Files for blood, blood components and haematopoietic progenitor cells
<http://www.tga.gov.au/manuf/tmf_blood.htm>
Contact details for enquiries about blood & tissues
If your enquiry is not specifically about blood & tissues, see: Contact the TGA <http://www.tga.gov.au/contact.htm>
Enquiries about blood & tissues
- Email: bloodandtissues@tga.gov.au
- Phone:
- Enquiries about blood: 02 6232 8291
- Enquiries about tissues: 02 6232 8685
- 1800 020 653 (freecall within Australia)
- 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 020 653
- Speak and listen (speech to speech relay) users phone 1800 555 727 then ask for 1800 020 653
- Fax: 02 6232 8687
- Post: Office of Devices, Blood & Tissues, TGA, PO Box 100, Woden ACT 2606, Australia