TGA Sponsor Obligations: ARTG Inclusion and Adverse Event Reporting

Who counts as a sponsor and what they must do

Under the Therapeutic Goods Act 1989, a sponsor is the entity in Australia responsible for a therapeutic good's importation, manufacture or export. Therapeutic goods, including medicines, biologicals and medical devices, generally must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied.

The Therapeutic Goods Administration (TGA) regulates sponsors throughout the product lifecycle, covering pre-market, market authorisation and post-market activities. Sponsors must comply with conditions of inclusion attached to their ARTG entries. Therapeutic Goods Advertising Code provides guidance on advertising therapeutic goods.

Sponsors are legally responsible for meeting reporting and quality obligations, regardless of the marketing status of the therapeutic good.

ARTG inclusion pathways

Products seeking inclusion on the Australian Register of Therapeutic Goods (ARTG) follow distinct pathways. Medicines are either ‘registered’ – typically for products with a higher risk profile – or ‘listed’, which applies to products considered lower risk. Biologicals are managed under a separate inclusion framework.

Medical devices are classified according to risk, ranging from Class I to Class III, and including Additional Medical Devices (AIMD) and In Vitro Diagnostics (IVDs). Inclusion on the ARTG requires the submission of evidence demonstrating safety, quality and, for higher-risk goods, either efficacy or performance.

Generally, all products seeking ARTG inclusion require a sponsor declaration and conformity assessment evidence. The specific requirements for this evidence are determined by the product’s classification and risk profile.

Pharmacovigilance and adverse event reporting

Sponsors are required to establish and maintain a system for collecting and documenting all adverse reactions occurring in Australia, regardless of the source. This system must ensure comprehensive capture of information related to the safety of their products.

Serious adverse reactions to medicines must be reported to the TGA within 15 calendar days of the sponsor’s initial receipt of the information. Sponsors can fulfil this reporting obligation through the Adverse Event Management System (AEMS) or via electronic data interchange using the E2B R2 format.

A key responsibility for sponsors is the nomination of an Australian-based Pharmacovigilance Contact Person (A-PVCP). The TGA must be notified of this nomination, or any subsequent changes to the A-PVCP, within 15 calendar days of the inclusion or change. Note that medical device sponsors are subject to different adverse event reporting timeframes outlined in the medical device regulations.

Post-market monitoring and enforcement

Once a medicine is included on the Australian Register of Therapeutic Goods (ARTG), sponsors retain obligations relating to its ongoing performance. Sponsors must monitor the safety, quality and performance of their goods. For higher-risk medicines, periodic safety update reports (PSURs) may be required.

Should issues arise requiring corrective action, recalls and product corrections must be undertaken in cooperation with the TGA. This ensures appropriate communication and management of risks to public health. AHPRA Health Practitioner Regulation National Law plays a role in ensuring professional conduct related to therapeutic goods.

The TGA retains the power to enforce compliance with these obligations. This includes the ability to cancel ARTG entries, impose conditions on registration, or refer matters for prosecution. Criminal and civil penalties apply for unlawful supply, providing false ARTG information, or failing to report adverse events.