Consultation: Adoption of International Scientific Guidelines in Australia - closed February 2022

The Therapeutic Goods Administration (TGA) conducted a public consultation to seek feedback on whether certain international scientific guidelines should be adopted.

International scientific guidelines are not limited to prescription medicines, but may also apply to over-the-counter (OTC), complementary and some listed medicines. While guidelines that are adopted in Australia are generally not mandated by legislation, they provide guidance to sponsors to assist them to meet the legislative requirements and any deviation from a Guideline relevant to an application to register or vary the registration of a medicine must be justified.

For more information on the international scientific guidelines, and to participate in the consultation, please visit the consultation hub.

Timetable

The consultation opened on Monday 10 January 2022. Interested parties responded by close of business Sunday 20 February 2022.

Enquiries

For enquiries relating to the consultation or your submission please email euguidelines@health.gov.au.

All recent TGA consultations can be found at the TGA consultation hub.