As part of ARCS’s initiative to provide more opportunities for members to connect with peers and regulators, the inaugural ARCS Regulatory Affairs Summit was held in February 2025. Over 130 regulatory professionals across the pharmaceutical and medical sectors, as well as over 20 regulators from the Therapeutic Goods Administration (TGA)attended the Summit in Canberra to discuss pressing issues and future directions in regulatory policy. This year’s summit, developed in collaboration with the TGA, dived into key issues surrounding prescription medicines, both pre- and post-marketing application processes, and the challenges around topics including TGA’s priority determination process, work-sharing and expedited regulatory pathways, application common deficiencies, Labelling Order updates, the evolving landscape of post-approval change management under ICH Q12, and TGA reforms.

As presenters and facilitators at the Summit, we had the privilege of sharing insights from the discussions and engaging with an audience keen to understand how these changes impact their work. The themes were clear: early engagement with the TGA is crucial, industry must be proactive in regulatory strategy, and ICH Q12 represents an evolving but inevitable shift toward a more flexible, risk-based approach to the  management of post-approval changes and product lifecycle management.

Unlocking Priority Determination: What You Need to Know

One of the key takeaways from the Summit was a detailed discussion led by Dr. Nitin Bagul from the TGA on the priority determination process. that is designed to fast-track the evaluation of new medicines for serious conditions, ensuring quicker patient access to life-saving treatments.

A crucial point raised during the session was timing—the TGA recommends engaging with them at least three months before submission. However, once granted, the full dossier must be submitted within six months, making careful planning essential.

The criteria for priority determination remain a topic of active discussion. While the requirement that the medicine be new and treat a serious condition is straightforward, there was considerable debate around what constitutes a “major therapeutic advance”. Many sponsors raised concerns that TGA’s assessment of significant benefit can be subjective, particularly when comparing new therapies to existing treatments.

Attendees also questioned whether the TGA considers accelerated approvals from other jurisdictions, such as the FDA or EMA, when granting priority determination in Australia. While TGA considers accelerated approvals overseas, each application is assessed on its own merits, making clear, data-driven justification essential.

ICH Q12: The Future of Change Management

The Summit also featured a discussion on ICH Q12 and its implications for post-approval change management, presented by Vishal Kaushik and Jacinta Watt from the TGA.

ICH Q12 introduces a risk-based framework for managing post-approval changes, offering tools such as Post-Approval Change Management Protocols (PACMPs) and Established Conditions (ECs), and the concept of a Product Lifecycle Management (PLCM) Document  to bring more predictability and efficiency to regulatory submissions.

In practice, these tools allow sponsors to define and pre-agree on certain regulatory changes, reducing the burden of future submissions and the reliable supply of product into the market. When implemented, ICH Q12 will allow regulators to better understand a manufacturers’ Pharmaceutical Quality Systems (PQS) for management of post-approval chemistry, manufacturing & controls (CMC) changes.

However, while global regulators, including the FDA and EMA, have begun implementing aspects of ICH Q12, TGA’s adoption remains in the early stages. For context, a key point raised during the discussion was around the guideline, and how it misaligns with existing local regulatory frameworks in overseas regulatory jurisdictions. As a result, adoption across ICH Member States and Observers as a whole has been slow.  TGA is currently conducting a gap analysis to understand how Australia’s regulatory framework can accommodate these tools, particularly for minor variations in chemical and biological medicines.

Industry professionals queried the complexity of implementing ICH Q12, particularly for smaller companies unfamiliar with these regulatory concepts. A potential solution discussed was a staggered adoption process, where ICH Q12 principles are first introduced for traditional pharmaceuticals, followed by biological prescription medicines. As has been the case in overseas regulatory jurisdictions, a pilot activity focusing on implementation may also be an option considered by TGA.

Takeaways and Looking Ahead

The Summit reinforced the importance of early regulatory engagement and proactive planning. Key messages for regulatory professionals included:

• Plan early: Engage with the TGA before major submissions.

• Prepare robust justifications: Clearly demonstrate clinical benefit to strengthen your application.

• Stay informed: Adoption of new guidelines such as ICH Q12 may seem slow but inevitable—understanding risk-based change management will be crucial.

• Watch for upcoming regulatory consultations: The TGA will seek industry feedback on proposed changes, making it vital for professionals to stay engaged.

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With the evolving regulatory landscape, industry professionals must anticipate changes and adapt their registration and post-market strategies accordingly. Whether seeking priority determination for new therapies or navigating post-approval changes, the message from the ARCS Regulatory Affairs Summit was clear: being informed, proactive, and engaged with regulatory agencies is the key to success.

As ARCS continues to provide platforms for discussion and learning, we encourage all professionals to stay involved and contribute to shaping Australia’s regulatory future.

We would like to thank ARCS, the TGA, and the Regulatory Affairs Summit Committee (RASC) members* for their support with the planning and preparation of this event. 

RASC members - Anthony McGuire, Elaine Blair, Michelle Hyatt, Shanthi Vijayakumar, Stacey Lawrence.

For more insights and updates, visit the ARCS website and stay tuned for future webinars and summits.