Your Regulatory Impact Assessment Agent for Turning Change into Action Watch Ria in Action
June 2026Australia’s Therapeutic Goods Administration (TGA) has updated the dossier requirements for non-prescription medicines, including over-the-counter (OTC), assessed listed, and listed medicines. From 07 July 2026, eligible applications must be submitted in electronic Common Technical Document (eCTD) format.
The CTD is organized into five modules covering administrative information, quality summaries, quality data, non-clinical safety data, and clinical efficacy data. Assessed Listed Medicines follow a simplified CTD structure to support more efficient regulatory review.
The guidance also explains application requirements for listed medicines, which are considered low-risk products and can be included in the Australian Register of Therapeutic Goods (ARTG) based on sponsor certification without a full pre-market assessment.
Additional guidance covers application preparation, mandatory submission requirements, and regulatory updates, including provisions for therapeutic sunscreens. The revised framework aims to improve submission consistency, streamline regulatory reviews, and support faster market access for eligible non-prescription medicines.
Region: Australia
Reach out to us and let’s unravel your Regulatory puzzle together. Unlock regulatory solutions with our global subject matter experts and tap into a wealth of regulatory intelligence.
Speak to an Expert
