PV Bulletin

Update to listed medicine ingredients in June 2026

The Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2026 has been updated, introducing changes to the requirements for several listed medicine ingredients.

Primary source: https://www.tga.gov.au/news/news-articles/update-listed-medicine-ingredients-june-2026

PV Impact Brief

Urgency: HighConfidence: high

What changed

The requirements for several listed medicine ingredients have been revised, necessitating compliance with new permissible ingredients and updated safety requirements.

Why it matters

These changes affect the formulation and safety compliance obligations for sponsors of listed medicines, impacting product availability and market adherence.

Action needed

Sponsors must align their products with the updated safety and formulation requirements for permissible ingredients as per the new determination.

Relevant for
Regulatory Intelligence LeadQPPV
Processes impacted
Country Compliance
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Policy change details

Document type
Notice
Policy status
final
Publication date
2026-06-18
Policy change
The Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2026 has been updated, introducing changes to the requirements for several listed medicine ingredients, including additions of new substances and changes to existing entries.

Key changes

Addition of new permissible ingredients and update of safety requirements/restrictions for existing ingredients in the Therapeutic Goods Determination.

Affected workflows

Country Compliance

Responsible groups

Regulatory AffairsProduct Safety

PV impact

Sponsors of listed medicines must ensure that their products comply with the updated safety and formulation requirements for permissible ingredients.

View regulator source

Evidence and confidence

Confidence: highSource updated: Jun 18, 2026

Full briefing

Practical implication

Sponsors must align their products with the updated safety and formulation requirements for permissible ingredients as per the new determination.

The TGA has updated the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2026, implementing new permissible ingredients and modifying safety requirements for existing ones. Sponsors of listed medicines must now ensure compliance with these updated safety and formulation standards.

What changed: The requirements for several listed medicine ingredients have been revised, necessitating compliance with new permissible ingredients and updated safety requirements.

Why it matters: These changes affect the formulation and safety compliance obligations for sponsors of listed medicines, impacting product availability and market adherence.

Practical implication: Sponsors must align their products with the updated safety and formulation requirements for permissible ingredients as per the new determination.

View original source

Published from the Firecrawl policy change extraction pipeline.

#Safety Signals#Therapeutic Goods Administration (TGA)#final#policy-change#Guidance#firecrawl-policy-agent#Notice

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