TGA communicates proposed transitional arrangements for reform of Orphan Drug programme

The Australian Therapeutics and Goods Administration (TGA) has announced the proposed arrangements for Orphan Drug designations that were received since the commencement of the Orphan Drug programme.

Reform of the Australian Orphan Drug Programme is soon to introduce additional eligibility criteria, as follows:

  • Life threatening or seriously debilitating condition; and
  • No existing therapeutic goods for prevention diagnosis or treatment, or significant benefit over existing therapeutic goods; and
  • Medical plausibility

To ensure that the fee waiver is granted on the basis of meeting the eligibility criteria, the validity of the designation is proposed to lapse after 6 months, with the option to apply for a 6 month extension.  This is different to the current Orphan Drug designation that does not involve the re-assessment of eligibility over time.

What does this mean for existing Orphan Drug designations?

A transition period is proposed for existing Orphan Drug designations which were granted prior to the reform programme, at a time when their status would not lapse.  The TGA proposes that all existing Orphan Drug designations will lapse 12 months after the introduction of the revised programme.  This will give sufficient time for sponsors to address the new requirement and to re-apply under the revised system.

The implementation of the proposed transition plan will involve the following (dates subject to necessary regulations being in place):

  • 1 July 2017 – New Orphan Drug regulations come into effect.
  • 1 July 2017 to 30 June 2018 – TGA recognises the validity of approved Orphan Drug designation applications that were lodged prior to 1 July 2017.
  • 1 July 2018 – All Orphan Drug designations based on an application lodged prior to 1 July 2017 lapse.

The proposed transition plan is out for consultation, with responses required by 19th May 2017.

To access the TGA announcement, please click here.