Consultation: Legislating regulatory categories for some boundary and combination products

Overview

The Australian Government is undertaking significant reforms to further improve regulation of therapeutic goods in Australia. The Therapeutic Goods Administration (TGA) is the government authority responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods including medicines, medical devices and biologicals.

Products that meet the legislative definition of a therapeutic good under the Therapeutic Goods Act 1989 (the Act) are regulated by the TGA and need to be included in the Australian Register of Therapeutic Goods (ARTG) before they can be imported, exported or supplied.

Therapeutic goods are regulated as one of the following categories:

• Medicines as defined under Section 3 of the Act,
• Biologicals as defined under Section 32A of the Act,
• Medical devices as defined under Section 41BD of the Act, and
• Other therapeutic goods (OTGs) which include goods like tampons and disinfectants.

Products that fall under these categories have different regulatory pathways and requirements.

Some products may have attributes of two or more categories and the appropriate regulatory pathway is not immediately obvious. These are referred to as ‘boundary products’. 

Some products contain more than one type of therapeutic good with more than one therapeutic action or effect. These are referred to as ‘combination products’.

The regulatory category of these products is determined by a few factors, including the principal therapeutic effect of the product, therapeutic claims and intended use.

For more information and examples of boundary products see our Guidance on Boundary and Combination Products

This consultation

Feedback received in the previous consultation indicated the need for additional clarity and transparency on the appropriate regulatory pathways for some boundary and combination products.

Therefore, in this consultation, we are seeking feedback on:

• Whether legislating some products where possible to formally declare their regulatory category (e.g., medical device, not a medical device or OTG), will provide additional clarity for stakeholders.
• Whether a transitional period of five years is sufficient for sponsors of affected ARTG entries.

The survey:

The proposals are listed in a questionnaire format for your feedback. Click on the link ‘Consultation Questions’ available at the bottom of this page to provide feedback. On the ‘Introduction’ page, there are questions seeking information about yourself and a mandatory question regarding consent to publish your feedback. After you finish responding to questions on this page, click on ‘Continue’ button to view questions on the next page. Respond to the questions on the page ‘Proposal 1: Legislating regulatory category of some products’ and click on ‘Continue’ button to move to the next page and continue responding to the proposal on that page. Your response will not be submitted until you click on ‘Submit Response’ button on the ‘Almost done…’ page.

Please contact the TGA by email at: devicereforms@tga.gov.au if you have any questions or concerns related to this consultation.