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Australia: Understanding the Therapeutic Goods Administration's (TGA) Recall Reforms and the Introduction of the PRAC – January/February 2025

Australia: Understanding the Therapeutic Goods Administration's (TGA) Recall Reforms and the Introduction of the PRAC – January/February 2025

  • 2025-01-22 07:36:15

The Therapeutic Goods Administration (TGA) has introduced the Procedure for Recalls, Product Alerts, and Product Corrections (PRAC) to streamline and enhance the recall processes for therapeutic goods in Australia. By reducing recall categories, simplifying procedural steps, and improving communication, the PRAC aims to foster efficiency and clarity for manufacturers and regulatory consultants. With implementation set for March 2025, stakeholders are encouraged to prepare for these reforms to ensure compliance and contribute to a safer therapeutic goods landscape.

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Australia: TGA Issues Reminder on Advertising Rules for Therapeutic Goods: Key Guidelines for Social Media Compliance – October/November 2024

Australia: TGA Issues Reminder on Advertising Rules for Therapeutic Goods: Key Guidelines for Social Media Compliance – October/November 2024

  • 2024-11-05 02:13:00

The Therapeutic Goods Administration (TGA) has issued a reminder to manufacturers and marketers to comply with advertising rules for therapeutic goods, particularly on social media, following a rise in non-compliance cases. Key rules include ensuring ads are truthful, promoting only registered goods, adhering to endorsement guidelines, avoiding unapproved uses, clearly presenting risks and health warnings, and ensuring influencer content meets regulatory standards.

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