Pre-submission meetings with TGA

Consider alternatives

A meeting may not be necessary. You may be able to resolve your issues by:

• checking relevant guidance on our website and adopted EU guidelines
• phoning or emailing us for advice
• using the Early Scientific Advice pathway
• engaging a regulatory affairs consultant

Purpose of pre-submission meetings

A meeting could help you and the TGA:

• reach a shared understanding of the therapeutic good
• clarify what documentation is required for evaluation
• identify issues to resolve before submitting applications
• plan for the submission timing and resource needs

Important
We can discuss concerns regarding existing studies or the proposed data package, but what to include in the application remains your decision

We generally do not advise on the number or design of studies required

We have not reviewed the data yet, so we cannot advise you on anything that depends on full data evaluation 

When pre-submission meetings are most useful

Meetings are often beneficial for:

• complex therapeutic goods
• new or emerging technologies (including 'first in class' medicines,)
• combination goods (e.g. a medicine device combination product)
• medicines with a companion in vitro diagnostic (IVD)
• products with multiple related applications.

When pre-submission meetings are strongly recommended

Prescription medicines

Proposed applications involving:

• novel biological medicines and new vaccines
• biosimilars (especially first biosimilars; botulinum toxin; low molecular weight heparins)
• development programs diverging from TGA-adopted EU guidelines
• new generics of non-biological complex drugs (e.g., glatiramer, sevelamer)
• levothyroxine and carbimazole
• new generics of medicines for inhalation

Non-prescription medicines

Proposed applications involving:

• herbal preparations
• novel or emerging technologies
• specific regulatory issues (e.g. most appropriate pathway, methods diverging from TGA or TGA-adopted guidelines)
• proposed 0062 for assessed listed medicines
• new generics of complex registered complementary medicines

Other products

• new Class 2, 3, and 4 biologicals (including CTA applications)

Step 1: Complete the meeting request form

Meeting request form

Your meeting request form must include enough detail for us to:

• determine whether a meeting is necessary
• identify the right experts to attend

Indicate whether you prefer a teleconference, videoconference or in person meeting.

Step 2: Email your request

Send the completed form 4 weeks to 2 months before your proposed meeting date to:

• Prescription medicines: streamlinedsubmission@tga.gov.au
• Non-prescription medicines: nonprescriptionmedicines@tga.gov.au
• Biologicals: send to the relevant TGA office
• Biologicals: bloodandtissues@health.gov.au

If meeting outside Canberra, you must organise the venue.

Step 3: Advise attendees

List all attendees in the form, including consultants and their affiliations.

Meeting duration

Most meetings run for 1 to 1.5 hours, unless agreed otherwise.

TGA response

We will:

• assess your request
• confirm if a meeting is appropriate
• propose a mutually suitable time

Meetings may not need to proceed if your issues can be resolved without one.

Prepare a briefing package

Provide a briefing package so all participants can prepare effectively.

Include:

• an agenda
• a concise summary of key information about the therapeutic good
• supplementary information relevant to your meeting objectives
• any specific questions for the TGA
• summaries of relevant studies
• an explanation of any deviations from current guidelines or practices
• a discussion of key issues related to study design or quality of evidence (such as the use of a surrogate endpoint, reliance on a single study, use of a non-inferiority or adaptive design)
• list of questions for the TGA
• full meeting presentation and slides

Do not include:

• detailed data or full study/trial reports
• promotional material for the company or the therapeutic good

Structuring the briefing package

Organise content clearly, according to the agenda. Include:

• page numbers
• a table of contents
• appendices
• cross-references
• document formats to guide navigation such as tabs, if helpful

Follow the checklist in the meeting request form.

Send the briefing package

Email the full briefing package at least two weeks before the meeting to the same address used to request the meeting.

Rescheduling or cancelling

Avoid rescheduling unless necessary. Notify us early if changes are unavoidable. 

TGA may cancel or reschedule a meeting if:

• we do not receive the full briefing package and agenda at least two weeks prior to the meeting date
• the full briefing package does not contain sufficient information for us to provide guidance

Keep presentations concise.

A TGA officer will open the meeting and will confirm:

• discussion will focus only on pre-identified issues
• no new material may be presented unless provided at least 48 hrs beforehand
• the meeting is not to include product promotion
• no audio or video recording is permitted
• the sponsor is responsible for drafting the minutes and circulating to all participants within two weeks of the meeting date
• all advice given in the meeting is general advice, non-binding, and given in good faith

All attendees should summarise key points, agreements, clarifications and action items.

• Complete a meeting record (use the meeting record form, if desired), which provides a summary that clarifies the agreed outcomes, and any actions arising.
• Send a record to all participants within two weeks.
• We will acknowledge receipt within two weeks.
• Include the final record in module 1 of the application dossier