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19 May 2020

If you are a health professional who handles biologicals, it is important you understand parts of the Regulatory Framework for Biologicals.

Understanding the regulatory framework for biologicals

What is regulated as a biological
Not everything that meets our definition of a biological is regulated as a biological. This guidance explains what therapeutic goods will be regulated as a biological.

Pathways for supply biological products
All products regulated as a biological must be included on the ARTG, unless they are exempt, or an 'unapproved' biological authorised for supply.

Unapproved biologicals

Unapproved biologicals
If you need to access biologicals that are not included on the ARTG, this guidance will outline the procedures available and the circumstances under which they can be used.

Autologous human cells and tissue regulation

Autologous human cell and tissues products regulation (HCTs)
How we apply regulation, based on the risk associated with the product, and when exclusions and exemptions apply.

Excluded autologous HCTs
How to determine when autologous HCTs are eligible for exclusion from TGA regulation.

Exempt autologous HCTs
Understand if your product is exempt from some aspects of TGA regulation. It also explains what regulation does apply to exempt autologous HCT products.

Regulation of stem cell treatments: information for practitioners
Introduction to the regulatory requirements for practitioners that provide stem cell treatments.

Autologous human platelet-rich plasma and conditioned serum

Autologous human platelet-rich plasma and conditioned serum
What they are and how they are regulated.

Faecal microbiota transplant (FMT) products

Faecal Microbiota Transplant (FMT) product regulation
What they are and how they are regulated.