TGA Pre-Submission Meetings
A Strategic Advantage
In April 2026, the Therapeutic Goods Administration (TGA) updated its guidance on pre-submission meetings for medicines and biologicals. This signals emphasis on early, structured engagement between sponsors and regulators. For regulatory teams, this is not a procedural update; it is a strategic opportunity to reduce submission risk, enhance clarity, and avoid costly delays later in the lifecycle.
TGA pre-submission meetings have always existed, but their value can be misunderstood. Some teams might treat them as a checkpoint or approval gateway; others avoiding them entirely due to perceived effort or uncertainty about outcomes. The updated TGA guidance reinforces a more nuanced position: these meetings are neither mandatory nor determinative, but when used well, they can significantly improve submission quality and readiness, help manage regulatory expectations and protect investments.
This blog explains how to use TGA pre-submission meetings as a risk‑management tool. It focuses on practical strategies for planning, executing and translating meeting outcomes into actionable submission plans.
What a pre-submission meeting is (and is not)
A TGA pre-submission meeting is a formal opportunity for sponsors, manufacturers or agents to engage with the regulator before submitting an application. The purpose is to:
- clarify key issues,
- align understanding of the therapeutic good,
- and identify potential challenges early.
Importantly, these meetings are not a substitute for dossier assessment. The TGA explicitly states that it has not reviewed full data at this stage and cannot provide advice that depends on detailed evaluation. Sponsors remain responsible for determining what to include in their application.
The TGA may discuss concerns about existing studies or proposed data packages, but it generally does not advise on the number or design of studies required. This distinction is critical. Teams expecting prescriptive direction often leave disappointed, while those prepared for high‑level guidance extract meaningful value.
Another important limitation is that meeting outcomes are non‑binding. Guidance provided reflects the understanding at that time and may evolve as knowledge develops or as the regulator reviews the full dataset.
A sponsor developing a novel biological therapy seeks confirmation that its clinical programme is sufficient. In the meeting, the TGA reframes the discussion toward risk areas and potential evidence gaps, rather than confirming adequacy. The sponsor uses this insight to strengthen their submission strategy, without assuming endorsement.
When pre-submission meetings add the most value
Pre-submission meetings are most effective when the regulatory pathway is uncertain or complex. The TGA highlights that meetings are particularly beneficial for complex therapeutic goods, emerging technologies, and combination therapeutic goods.
Helpfully, the TGA also specifies scenarios for which meetings are strongly recommended, for both prescription and non-prescription products. Early dialogue can be particularly useful in situations which carry higher scientific and regulatory uncertainty.
But consider whether or not a meeting is necessary, such as for routine or well‑established applications. The TGA suggests considering whether existing guidance, email queries, or an industry consultant could resolve questions more efficiently.
A sponsor uncertain about a single stability testing requirement opts for written clarification rather than a full meeting. This resolves the issue quickly and preserves meeting requests for more complex topics later.
Practical guidance – how to get real value from a meeting
How to request a pre-submission meeting
Pre-submission meeting requests should be emailed on the approved form and must include sufficient information as specified by the TGA, to assess necessity and assign appropriate experts. The regulator uses this information to accept, decline or suggest alternatives.
Sponsors should submit requests several weeks in advance (typically 4 to 8 weeks before the proposed date). A clear purpose and defined topics increase the likelihood of acceptance.
NOTE! Ensure you submit to the correct email address. Also be aware that for meetings outside Canberra, you are responsible for arranging the meeting venue.
Writing a high‑impact briefing package
A strong briefing package is the single biggest driver of meeting value.
Focus on:
- Clear presentation with suitable page number and table of contents
- Clear product description and development stage
- Defined problem statements (not just background)
- Proposed regulatory strategy
- Specific, answerable questions
The full briefing package should be provided electronically 2 weeks before the meeting.
Briefing package checklist
- Proposed agenda – meetings are expected to run for 1 to 1.5 hours unless otherwise agreed
- Product overview (indication, modality, lifecycle stage)
- Meeting objectives
- Identified risks, uncertainties or regulatory deviations
- Summary of studies and data, and key issues relating to these
- Proposed approach or position
- A list of proposed questions, grouped by discipline
- A list of attendees, including titles and affiliations
- Meeting presentation – should be provided no later than 2 days before the meeting and should not include any information additional to the full briefing package. This may cause the meeting to be postponed.
During the pre-submission meeting
Pre-submission meetings typically involve TGA technical experts and sponsor representatives.
Best practice includes:
- Assigning a facilitator and a lead technical spokesperson
- Managing time tightly around key questions
- Capturing decisions, clarifications and open items in real time – a meeting record form is available for use by the Sponsor
Most importantly, distinguish between:
- Clarifications (high confidence takeaways)
- Contextual comments (interpretive insights)
- Non‑answers (signals requiring further work)
After the pre-submission meeting: turning insight into action
The meeting itself does not reduce risk; what you do afterwards does.
Translate outcomes into:
- A gap analysis (what evidence or justification is missing)
- A refined evidence generation plan
- Updated submission timelines and milestones
Post-meeting checklist
- Document key messages and areas of alignment
- Identify clarified vs unresolved issues
- Submit the meeting record to all participants within 2 weeks
- Update regulatory strategy document
- Revise study or evidence plans if needed
- Align internal stakeholders (clinical, quality, regulatory)
- Establish internal decision gates linked to meeting outcomes
- Track risks and mitigation actions
- Confirm any follow‑up queries with TGA if required
Additional governance layer: what good looks like
High‑performing organisations embed pre-submission meetings into governance processes. They treat them as structured decision gates, not ad hoc engagements.
Key features:
- Cross‑functional preparation workshops
- Formal sign‑off of briefing packages
- Decision logs linked to programme milestones
- Integration with global regulatory strategy
This approach ensures that insights are proactively managed and not lost.
Potential pitfalls
- Treating the meeting as a “pre‑approval” step rather than a discussion.
- Asking broad or unfocused questions that cannot be answered effectively.
- Providing excessive background with limited problem definition.
- Expecting the TGA to design or validate study programmes.
- Failing to propose a sponsor position for discussion.
- Bringing too many participants, reducing discussion efficiency.
- Not capturing decisions or key points during the meeting.
- Over‑interpreting informal comments as regulatory commitments.
- Ignoring alternative pathways that could resolve simpler questions faster.
- Failing to translate outcomes into a concrete submission plan.
- Submitting poorly structured briefing packages, reducing meeting value.
- Requesting meetings for low‑complexity applications where guidance already exists.
Making pre-submission meetings work for you
TGA pre-submission meetings are a powerful but under‑utilised tool. When used strategically, they can clarify expectations, highlight risks and improve submission readiness. However, they are not a shortcut to regulatory certainty.
The key to success lies in preparation, focus and disciplined follow‑through. Organisations that treat these meetings as part of a broader governance framework consistently extract more value and reduce downstream surprises.
Action steps:
- Assess whether your application genuinely requires a meeting
- Use alternative pathways for narrow or clarifiable issues
- Invest in a high‑quality, focused briefing package
- Ask targeted, decision‑oriented questions
- Capture and categorise meeting outcomes clearly
- Translate insights into a formal submission and evidence plan
PharmOut Services & Training
PharmOut supports sponsors preparing for TGA pre-submission meetings by helping clarify regulatory strategy, identify potential risks, and develop focused, high‑quality briefing packages. Our experienced consultants can facilitate preparation workshops, review proposed questions, and stress‑test your submission approach. We also provide targeted training to build internal capability in regulatory planning and engagement. Explore our services via Medical Device and Pharmaceutical Consultants or contact us to tailor support to your programme needs.
Explore elearning and public courses via onlinegmptraining.com, or contact us via the website or via email to tailor workshops to your needs.
Frequently Asked Questions (FAQ)
No, they are optional and should be used selectively where complexity or uncertainty justifies early engagement.
No, the TGA does not evaluate full data at this stage or provide binding confirmation of adequacy.
Typically 5–10 focused, decision‑relevant questions deliver the most useful outcomes.
For complex, novel, or first‑in‑class products, or where the regulatory pathway is unclear.
As input to refine your submission strategy, identify gaps, and update your evidence and timeline plans, not as formal regulatory commitments.
