.png)
The Therapeutic Goods Administration (TGA) has announced significant updates to its recall process, slated for implementation in early March 2025. These reforms will replace the current Uniform Recall Procedure for Therapeutic Goods (URPTG) with the new Procedure for Recalls, Product Alerts, and Product Corrections (PRAC). Below, we explore the key changes and their implications for sponsors and stakeholders in Australia’s therapeutic goods industry.
Key Features of the PRAC
Enhanced Communication and Transparency: PRAC aims to improve the timeliness and clarity of information shared with stakeholders and the public, ensuring swift and effective action during recalls.
Simplified Market Action Categories: The eight existing recall categories will be reduced to four, eliminating confusion and making the process more straightforward.
Streamlined Procedures: The number of steps in the recall process will be halved – from ten to five – simplifying administrative workflows without requiring major changes to sponsors’ existing approaches.
Improved Usability: With fewer pages, less repetition, and clearer instructions, PRAC provides sponsors with user-friendly templates and guidance for managing recalls efficiently.
Unified Terminology: PRAC eliminates the distinction between “recall” and “non-recall” actions, introducing a single category called “market actions” for all activities.
Retained Reforms from URPTG 2024: Key updates from previous URPTG, such as flexible reporting requirements, the “Early Advice” process, and new templates, will be carried forward.
IT System Enhancements
To support the PRAC, TGA will launch updates to its IT systems including:
Database for Recalls, Product Alerts, and Product Corrections (DRAC):
Formerly the System for Australian Recall Actions (SARA), DRAC will provide enhanced access to information about recalls and market actions.
TBS Portal Updates: Upgraded features will simplify reporting and improve communication with TGA
Benefits for Stakeholders
Reduce regulatory burdens for sponsors through streamlined processes and reduced administrative tasks
Enhance consumer and patient safety by minimizing delays in addressing unsafe products
Foster greater stakeholder confidence through clear and consistent communication
Preparing for the Transition
Sponsors should continue following the URPTG until the PRAC takes effect in early March 2025. TGA will announce the precise implementation date closer to the transition.
To help stakeholders adapt to the new procedure, TGA will host public webinars to provide detailed insights into the PRAC and its implementation, ensuring a smooth transition for all involved.
Future Vision
By simplifying processes, updating IT systems, and leveraging legislative powers, PRAC represents a critical step forward in protecting public health. This final phase of reforms underscores TGA’s commitment to improving Australia’s recall processes and ensuring the safety of therapeutic goods for all consumers.
Comments