A Decision made by a delegate under the Therapeutic Goods Act (‘TG Act’) rejecting an application can be a harrowing setback for a business’s operations and timeline. The decisions made leading up to and, more importantly, in response to an Initial Decision are critical to keeping projects on track. Yet, many companies delay seeking legal advice at this stage and get caught up in the complexity of the review process—leading to costly delays and escalating challenges. Internal review by the Therapeutic Goods Administration (‘TGA’) under the section 60 of the TG Act presents a unique set of challenges. Consider, for example, the difficulty of returning competitively to the market after lengthy and disparaging internal review proceedings. Any requests for internal review under the TG Act must come within 90 days. During this time, companies should plan their approach pragmatically and consider the entire review procedure. This includes ensuring that all relevant information is lodged with the delegate before requesting reconsideration, as ostensibly fair new information provisions may prolong decision-making. Understanding how to avoid pitfalls during the internal review process can better position a company for external review, making for a streamlined entry or return into the market. External review by the Administrative Review Tribunal (‘ART”) provides another layer of review, and can override the decision of the TGA, but through a totally different process. The Applicant may want to lead the evidence of one or more experts, the proceedings against the TGA are in adversarial form, and the decision maker is independent. Any further review options are before a court, which can only review the “lawfulness” of the decision, rather than the merits of the decision. Geoff Bloom, Health & Life Sciences Partner at Mills Oakley and [TGA officer] will discuss the potential perils of poor internal review, how to identify and avoid pitfalls of the review process and provide practical tips for approaching proceedings with the TGA. Attendees will gain insights into navigating the review process to minimise disruption and maintain market competitiveness.