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
Blood & blood components
- Regulation of blood
<http://www.tga.gov.au/bt/blood.htm> - TGO 81 Standards for blood and blood components
<http://www.tga.gov.au/legis/tgo/tgo81.htm> - Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2007
<http://www.tga.gov.au/legis/mp0701.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)
- Current standards applicable to TGA-licensed HPC manufacturers
- Regulation of HPCs derived from cord blood - TGO 75 Standards for haematopoietic progenitor cells derived from cord blood
<http://www.tga.gov.au/docs/html/tgo75.htm> - Technical Master Files for blood, blood components and haematopoietic progenitor cells
<http://www.tga.gov.au/manuf/tmf_blood.htm>
Tissues
- Regulation of tissues
<http://www.tga.gov.au/bt/tissues.htm>
Blood & tissues
- Regulatory forms
<http://www.tga.gov.au/bt/forms.htm> - Australian code of good manufacturing practice - human blood and tissues
<http://www.tga.gov.au/manuf/gmpbltic.htm> - Presentations about blood & tissues regulation
<http://www.tga.gov.au/bt/presentations.htm>
What's new
- Consultation on proposed standards and Code of GMP (new)
7 December 2009 - TGA biologicals framework newsletter, Issue 2, December 2009 (new)
4 December 2009 - Biologicals framework implementation (updated)
4 December 2009
Biologicals regulatory framework
- Biologicals framework implementation
<http://www.tga.gov.au/bt/hct.htm> - Facility registration
<http://www.tga.gov.au/bt/hctfacilityreg.htm> - Biologicals framework newsletter
<http://www.tga.gov.au/bt/biologicals-newsletter.htm>
General regulatory information
- Medicines regulation & the TGA
<http://www.tga.gov.au/docs/html/medregs.htm> - Australian Register of Therapeutic Goods
<http://www.tga.gov.au/docs/html/artg.htm> - Glossary of terms & definitions
<http://www.tga.gov.au/web/glossary.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: 1800 678 799 (freecall within Australia)
- 02 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: 02 6232 8939
- Post: Office of Devices, Blood & Tissues, TGA, PO Box 100, Woden ACT 2606, Australia