Transition arrangements - Australian regulatory framework for biologicals

18 September 2012

The Australian regulatory framework for biologicals came into effect on 31 May 2011.

A three year transition period is specified in the Therapeutic Goods Act 1989 for manufacturers and sponsors of currently supplied biologicals to meet the new regulatory arrangements, including inclusion of biologicals in the Australian Register of Therapeutic Goods (ARTG). The transition arrangements are described in Appendix 12 of the Australian Regulatory Guidelines for Biologicals (ARGB) and the transition period ceases on 31 May 2014.

A key date for sponsors of currently supplied biologicals is 30 November 2012. Sponsors will be able to continue to supply a product until the TGA has reached a decision, even in the unlikely event that this decision is reached after 31 May 2014 if:

  • the biological was supplied prior to 31 May 2011
  • and
  • an acceptable application is received by the TGA for inclusion of the biological into the ARTG on or before 30 November 2012.

Special funding arrangements for the transition period

Special funding arrangements have been made by the Australian Government for funding of the direct regulatory costs for Australian publicly funded facilities and not-for-profit hospital supply units, and this continues until 31 May 2014. The 'direct regulatory costs' for biologicals include, but are not limited to:

  • application fees
  • dossier evaluation fees
  • variation fees
  • manufacturing inspection fees.

Facilities that have been given 'non-profit' status by the TGA in the past are required to re-apply to the TGA under the new arrangements.

Transition arrangements for inclusion into the ARTG

The transition arrangements for the Australian regulatory framework for biologicals apply to products that were supplied before 31 May 2011. New biologicals need to be included in the Australian Register of Therapeutic Goods (ARTG) before they can be legally supplied in Australia.

flow chart showing transition arrangements for biological products from 31 May 2012

New biologicals

New biologicals, which were not supplied prior to 31 May 2011, must meet the requirements of the framework before they can be legally imported, exported, supplied or used in Australia.

Currently supplied products

There are three types of currently supplied product:

  1. Biologicals that were previously exempt from ARTG entry but licensed for GMP by the TGA are exempt from inclusion in the ARTG until 31 May 2014.
    1. Sponsors need to apply for inclusion of a biological in the ARTG for the product before the transition period ends. During this period existing requirements in relation to the GMP licence will continue to apply.
  2. Biologicals that were previously exempt from both ARTG entry and GMP licensing requirements are exempt from these requirements until 31 May 2014. Sponsors need to:
    1. ensure that the manufacturer has applied to the TGA for a GMP licence
    2. after the GMP licence application has been made, the sponsor must lodge an application for inclusion of the biological in the ARTG during the transition period.

It is recommended that sponsors of products previously exempt or excluded from ARTG inclusion submit an application to include their product in the ARTG as a biological before 30 November 2012.

If an application is acceptable and is made before 30 November 2012, then a product will be able to be continually supplied until the TGA makes a decision on the application, even if this decision is made after 31 May 2014.

  1. Biologicals currently being supplied as therapeutic goods and included in the ARTG will continue to be on the ARTG. Sponsors do not need to take any action.
    1. Current entries on the ARTG will continue to be regulated under the old requirements until the TGA creates a new entry on the biologicals part of the ARTG and cancels the current entry. This will occur as soon as practicable, and the TGA will notify the sponsor once this has been completed. Supply of the product can continue without interruption throughout this process. There will be no fees payable for transferring products to the biologicals part of the ARTG. Only one set of annual charges for ARTG inclusion will be imposed for that product during the year of transfer.

Top of page