February 13, 2025

TGA Recall Reforms: A Closer Look at the PRAC

Earlier this month, we shared an update on LinkedIn regarding the Therapeutic Goods Administration (TGA) recall reforms and the introduction of the Procedure for Recalls, Product Alerts, and Product Corrections (PRAC). Given the significance of these changes, we wanted to expand on this topic, providing our clients and stakeholders with a deeper understanding of what’s changing, why it matters, and how to prepare.

The Shift from URPTG to PRAC

The TGA is replacing the Uniform Recall Procedure for Therapeutic Goods (URPTG) with the PRAC, which will come into effect on 5 March 2025. This transition aims to make the recall process more streamlined, transparent, and efficient. The reforms are designed to reduce administrative burdens while ensuring that product recalls and corrections are handled effectively to protect public health.

Key Changes Under PRAC

1. Simplified Market Actions

Previously, the TGA categorised actions into eight different types under the URPTG. With the PRAC, these have been consolidated into four clearer categories:

  • Recall – Removal of a product from the market due to safety concerns.

  • Product Alert – A notification to inform stakeholders about safety-related updates.

  • Product Correction – A modification or update to a product without removing it from circulation.

  • Quarantine – Temporary restriction of distribution pending further assessment.

This refinement eliminates confusion and makes it easier for sponsors to determine the appropriate course of action.

2. Streamlined Recall Process

The recall process has been reduced from ten steps to five, improving efficiency while maintaining regulatory oversight. This change aims to reduce administrative burdens on sponsors while ensuring effective recall actions. With clearer guidance, reduced repetition, and more flexible reporting options, the PRAC simplifies compliance with regulatory obligations.

3. New IT Systems and Tools

To support PRAC implementation, the TGA is enhancing its IT infrastructure, including the Database for Recalls, Product Alerts, and Product Corrections (DRAC), which will replace the current System for Australian Recall Actions (SARA). These upgrades will provide sponsors with better tools for managing recall notifications and reporting requirements.

Upcoming Webinar: Prepare for the Transition

To help stakeholders navigate these changes, the TGA is holding a public online webinar on the transition from the URPTG to the PRAC on 20 February 2025, from 2:00 – 3:30 pm AEDT. This session will provide insights into the new process and answer common questions. The webinar will be recorded and uploaded to the TGA website for those unable to attend live.

Register here: Webinar Registration

How KD&A Can Help

At KD&A, we specialise in regulatory compliance and can support your organisation in adapting to the new recall framework. Whether you need guidance on PRAC implementation, assistance with compliance strategies, or help with recall preparedness, our team is here to assist.

If you have questions or need expert support, get in touch with us via our website: https://kdas.com.au

For more details on the TGA’s recall reforms, visit the official update: TGA Recall Reforms Update

Stay informed, stay compliant, and let KD&A help you navigate these regulatory changes with confidence.