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Unapproved biologicals: pathways for access

Australian Regulatory Guidelines for Biologicals (ARGB)

6 November 2020

This guidance is for people who wish to access biologicals that are not included on the Australian Register of Therapeutic Goods (ARTG), and are not otherwise exempt from being in the ARTG.

Biologicals that have been entered on the ARTG have been evaluated for quality, safety and efficacy. However, if you want to access a biological that is not included on the ARTG (an 'unapproved' biological), there are several pathways, depending on whether the use is:

You do not need to use an unapproved goods pathway if the biological is exempt from being included in the ARTG. For example, certain autologous human cells and tissues are exempt.

The pathways for accessing 'unapproved' biologicals cannot be used to facilitate the commercial supply of therapeutic goods.

Who uses the pathways

Most of the access pathways require a medical or dental practitioner to make the notification or a request for approval. Patients cannot make the notifications or applications themselves.

To determine which pathway, if any, is appropriate, health practitioners can use:

Authorised prescriber scheme

In some circumstances a medical practitioner may be granted authority to become an authorised prescriber:

  • of a specified unapproved biological
  • to specific patients, or class of patients, in their immediate care with a particular medical condition.

The authorised prescriber must obtain approval from a Human Research Ethics Committee (HREC) or endorsement from a specialist college. The information will be reviewed by us to determine whether there are any safety concerns and that the requirements under the scheme have been met. You must receive an approval letter from us before supply can occur. Find out more about the Authorised Prescriber Scheme.

Special access scheme

You can use the Special Access Scheme for any regulated therapeutic good for a single patient on a case-by-case basis. Find out more about the three pathways in the Special Access Scheme (SAS).

Clinical trials

There are two clinical trials schemes:

  • clinical trial notification (CTN) scheme
  • clinical trial approval (CTA): an application scheme that is mandatory for a trial of any Class 4 biological, unless use of the biological in the clinical trial:
    • is supported by evidence from previous clinical use
    • has been approved for an equivalent indication from a national regulatory body with comparable regulatory requirements.

Before conducting a clinical trial you need to consider whether your product is a Class 4 biological:

For more information:

Manufacture in accordance with appropriate GMP

All biologicals that are accessed through unapproved goods pathways, must be manufactured in accordance with appropriate good manufacturing practice, unless there is an exemption in place. For example, there is an exemption from manufacturing in a GMP accredited facility for unapproved biologicals used in first-in-human clinical trials.

Version history
Version Description of change Author Effective date
V1.0 Original publication incorporating new legislative changes and information previously published on the TGA website.

Biological Science Section

Regulatory Guidance Team

July 2018
V1.1 Minor updates to reflect CTA name change Biological Science Section November 2020