Regulatory aspects for Biologic Product licensing in Australia

  • Sanjeev Kumar Maurya Amity University, India
  • Vikesh Kumar Shukla
  • Sunny Kumar Maurya
  • Prachi Kaushik


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.

Keywords: Biologicals, TGA, ARGB, Therapeutic Goods


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How to Cite
Maurya, S. K., V. K. Shukla, S. K. Maurya, and P. Kaushik. “Regulatory Aspects for Biologic Product Licensing in Australia”. International Journal of Drug Regulatory Affairs, Vol. 7, no. 2, June 2019, pp. 1-6, doi:10.22270/ijdra.v7i2.310.

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