Regulatory aspects for Biologic Product licensing in Australia
The TG Act defines biological as product made, from or containing, human cells or human tissues, lives animal organs, cells or tissues, and that is used to treat or prevent disease or injury, Diagnose a condition of a person and Alter the physiological processes of a person.
The Australian Regulatory Guidelines for Biologicals (ARGB) provide the keen information for manufacturers, sponsors, professionals in healthcare and also to public about the use of human cells and tissues based therapeutic goods, live animal cells, organs and tissues (1). These all products are Biologicals. This guideline is specially written for general public. If you are a sponsor or manufacture, this will:
- Explains the biological regulatory framework is applies to manufacturer’s product and their exemption conditions (1).
- Explains the Australian regulatory requirements for supplying of Biologicals
- Explains what is required for the market authorization as per TGA especially for Biologicals.
2. TGA [Internet]. TGA; 2019 [cited 2019 Feb 11]. Available from:
3. EMEA (European Medicines Agency) [Internet]. EMEA; 2019 [cited 2019 Jan 10]. Available from:
4. Therapeutic Goods (Things that are Biologicals) Specification 2017 (No. 1) [Internet]. TGA; 2017 [cited 2019 Jan 12]. Available from:
5. Therapeutic Goods (Things that are not Biologicals) Determination [Internet]. TGA; 2019 [cited 2019 Jan 25]. Available from:
6. ISO (International Organization for standardisation) [Internet]. ISO; 2019 [cited 2019 Jan 11]. Available from:
7. Current TG Act and TG regulations [Internet]. TGA; 2019 [cited 2019 Jan 19]. Available from:
8. TGA risk management approach to the regulation of therapeutic goods [Internet]. TGA; 2011 Sept 12 [cited 2019 Jan 24]. Available from:
9. ICH (International Conference on Harmonization) [Internet]. ICH; 2019 [cited 2019 Jan 15]. Available from:
10. Therapeutic goods act [Internet]. TGA; 1989 [cited 2019 Feb 10]. Available from:
11. Office of the Gene Technology Regulator [Internet]. TGA; 2019 [cited 2019 Jan 25]. Available from:
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