International consultation on medicines and biologicals


AusBiotech is seeking contributions from affected members as it considers its response to the Therapeutic Goods Administration’s (TGA) consultation on the International Medical Device Regulators Forum (IMDRF)’s ‘Boundary and combination products - medicines, medical devices, and biologicals’.

The consultation is now open and the TGA is seeking comment on its draft guidance with the purpose to assist national and international sponsors and manufacturers in determining the status of therapeutic goods that may not fit clearly within existing definitions for medicines, biologicals, or medical devices.

The draft guidance aims to provide clarity on which regulatory pathway is appropriate for therapeutic goods.

This draft guidance is intended to replace the existing guidance on boundary products, ‘Australian medical devices guidelines: 35. Device-medicine boundary products’, dated November 2005. The existing guidance is out of date and requires updating to reflect significant changes in the regulation of therapeutic goods since 2005, including the introduction of the biological regulatory framework and new requirements needed to appropriately regulate emerging types of products continually entering the market.

In this consultation, the TGA is seeking industry’s views on the following questions:

  • Does the draft guidance align with your understanding of what medicines, medical devices and biologicals are?
  • Are you aware of currently marketed products that are not in alignment with the definitions in this draft guidance, and if so, what are they?
  • Are special, interim arrangements required to ensure continued supply of products that have to date been represented and sold as a type of therapeutic good inconsistent with this guidance?
  • Are there any other issues that should be addressed in the draft guidance?

The International Medical Devices Regulatory Forum (IMDRF) is a voluntary group of medical device regulators that was formed in 2012 with the purpose of building on the strong foundational work of the Global Harmonization Task Force (GHTF) to promote a regulatory model that responds to emerging challenges while protecting and advancing public health and safety. Australia’s TGA is a current member of the Forum along with Brazil, Canada, China, the European Union, Japan, Russia, and the USA.

AusBiotech is currently consulting with its AusMedtech Regulatory Affairs Advisory Group to consider a submission in response to this consultation.

The public consultation is open until 20 November 2022 and AusBiotech encourages members to contact Karen Parr, Director Communications & Policy, by Friday 11 November 2022 to discuss how the draft guidance and/or consultation may affect their company.