Support for SMEs to navigate TGA regulations


Greater support for navigating Australia’s therapeutic goods regulation is now available for SMEs with SME Assist, a new TGA service, launched on Friday by the Minister for Health, the Hon. Greg Hunt MP.

SME Assist is designed to help SMEs and R&D groups who develop new medicines and medical devices to understand their regulatory and legislative obligations. It caters for both users who have not previously engaged with the TGA and also those SMEs who regularly interact with the regulatory authority.

AusBiotech has welcomed the TGA’s approach to this support and contends that a better educated SME sector would be a nation-building activity for Australia. A program that helps educate young companies will be well received, support the industry’s growth, support faster approval of medicines and medical devices and avoid unnecessary re-work.

The new service will provide targeted regulation information to help SMEs better understand whether their product is a therapeutic good and how it may be classified under the Therapeutic Goods Administration (TGA) regulation. Information will help SMEs ascertain their requirements to engage with the TGA; specify the SME’s import, supply, export and manufacturing responsibilities; and provide guidance for undertaking an application for their product to be assessed for marketing in Australia.

SME Assist will offer education and training in the form of webinars, presentations and face-to-face workshops to provide SMEs with relevant and up-to-date information. The first of these sessions will be held in mid-August and will cover topics such as sponsor obligations, manufacturing requirements, what the TGA considers when assessing a product and health product advertising.

SMEs will also receive access to a tailored triage support system, which will address regulatory enquiries that SMEs may have.

The five areas of support offered by SME Assist include:

  • SME Assist Entry Point;
  • Education and Training;
  • Decision-trees and other tools;
  • Triage and improve phone/email support; and
  • Data capture

The TGA says SME Assist will evolve over time to keep pace with changes, as therapeutic goods are a dynamic and continuously changing area of Australian regulation. New information, topics and training will be included in the service to ensure it continues to provide support for SMEs in navigating the regulatory landscape in Australia.

The service is now available on the TGA website.