New biologicals based on a parent biological

10 April 2017

This guidance is for sponsors of biologicals included in the Australian Register of Therapeutic Goods (ARTG) who want to make a change to that biological (parent biological) where the change creates a separate and distinct good (new biological).

Determine if the change creates a separate and distinct good is Step 3a of the process to vary a biological entry on the ARTG. There are separate definitions of ‘separate and distinct good’ for the lower risk classes (class 1 and 2) and the higher risk classes (class 3 and 4) in regulation 11A of the Therapeutic Goods Regulations 1990.

This guidance does not apply to biological medicines, which are prescription medicines.

Preparing your explanation

Prepare an explanation of how the new biological is based on the parent biological.

We will use this explanation to determine:

  • the extent to which the evaluation procedure can be abridged; and
  • how much to reduce the evaluation fee.

If you want to maintain two entries on the ARTG (the new biological and the parent biological) the new entry must have a different name from the parent entry.

How we reduce your fees

If we have information relating to the goods that enables the evaluation procedure to be abridged, we can reduce the evaluation fee (regulation 45(4) of the Therapeutic Goods Regulations 1990). The evaluation fee can be adjusted to reflect the level of supporting information and assessment required.

We will:

  • consider your explanation detailing how the new biological is based on a parent biological
  • consider the level of supporting data provided to support the application
  • determine the fee reduction on a case-by-case basis.

Application process

To apply for a new biological under section 32DD of the Therapeutic Goods Act 1989 refer to guidance provided in the Australian Guidelines for Biologicals.

The level of supporting information required depends on:

  • the degree of the change from the parent biological; and
  • the potential of the change to impact on the quality, safety and efficacy of the good.

Cancelling parent biological

If we approve your application for a new biological based on a parent biological, you may either:

  • maintain both entries (provided the entries have different names); or
  • cancel the parent biological from the ARTG.

Instructions on how to request to cancel an ARTG entry can be found on our website. Requests can be made through the TGA Business Services portal or by completion and submission of a paper form.

Version history

Version Description of change Author Effective date
V1.0 Published as part of Consultation: Guidance on variations to biologicals included in the Register Biological Sciences Section
Regulatory Guidance Team
September 2016
V1.1 Original publication Biological Sciences Section
Regulatory Guidance Team
March 2017