TGA Guidance: Mandatory Reporting of Medicine Shortages and Discontinuations

Sharan Murugan
4 hours ago
2 min read

Medicine shortages and discontinuations are a growing global concern, and Australia has established a robust regulatory framework to ensure early detection, transparency, and risk mitigation. The guidance Reporting a shortage or discontinuation of a medicine you supply (updated 13 April 2026) outlines the mandatory obligations for sponsors to report medicine shortages and discontinuations to the Therapeutic Goods Administration (TGA).

A medicine shortage occurs when supply is unlikely to meet normal or projected demand within the next six months.

A discontinuation refers to a permanent cessation of supply in the market, meaning the medicine will no longer be available to patients.

Background

Medicine shortages can significantly impact patient care, treatment continuity, and healthcare system stability. To address this, Australia introduced mandatory reporting requirements under the Therapeutic Goods Act 1989, requiring sponsors to notify the TGA of shortages and discontinuations.

Since 2019, these requirements have improved transparency through the Medicine Shortages Information Initiative, which publicly shares shortage data and management actions.

Scope

The guidance applies to sponsors of reportable medicines, including:

Prescription medicines (Schedule 4)
Controlled drugs (Schedule 8)
Certain non-prescription medicines defined under legislation

These medicines are classified as “reportable medicines” under Australian law.

Reporting Requirements

Sponsors must notify the TGA of:

Current shortages
Anticipated shortages
Permanent discontinuations

The notification must include critical details such as:

Nature and cause of the shortage
Expected duration
Affected strengths and dosage forms
Current stock levels
Availability of alternatives
Supply management strategies

This information helps regulators assess the severity and impact of shortages and implement mitigation strategies.

Mandatory Reporting Timeframes

Reporting timelines depend on the impact level of the shortage:

Critical shortages must be reported within 2 working days, with additional details provided shortly after
Other shortages must be reported within defined regulatory timelines

Sponsors must also provide updates and confirm when the shortage is resolved.

Publication and Transparency

Reported shortages are published in the TGA Medicine Shortages Database, allowing healthcare professionals and the public to access up-to-date information.

However, commercially sensitive information is excluded from public reports to protect confidential data.

Compliance and Enforcement

Failure to comply with reporting obligations may result in penalties under the Therapeutic Goods Act 1989.

The TGA actively monitors supply disruptions and may require sponsors to submit notifications if shortages are identified through other sources.

By mandating early reporting, detailed data submission, and public transparency, the system ensures that patients, healthcare providers, and regulators can respond effectively to supply disruptions, safeguarding public health.