A GMP pre-submission meeting is an opportunity for applicants (manufacturers, sponsors and agents) of medicines and biologicals to engage with the TGA early to discuss their planned GMP applications. These may include:
- GMP licensing (LI) initial applications and variations for Australian manufacturers
- GMP certification (CE) initial applications and re-inspections for overseas manufacturers
- GMP clearance (CL) applications for overseas manufacturers through inspection reliance.
Note:
- We provide advice to clarify any issues you have relating to existing guiding instructions
- We do not address issues that require detailed evaluation of evidence
- We do not provide regulatory advice
- The meeting outcomes are non-binding.
When a GMP pre‑submission meeting is most valuable
You should consider requesting a GMP pre-submission meeting when:
- You are constructing or significantly modifying a manufacturing facility in Australia
- This is your first interaction with the TGA in relation to GMP
- You are relying on overseas manufacturers and GMP evidence from Recognised Regulatory Authorities (RRA), and
- You are uncertain about the appropriate application type, regulatory pathway or application scope (Manufacturing steps)
- Your application is time sensitive (for example, to address a potential medicine shortage)
- The manufacturing process or supply chain is complex
Pre-submission meetings are generally not required for straightforward or routine GMP applications.
Alternatives to meetings
Consider whether a meeting is needed. You may be able to resolve any issues more effectively by:
- reviewing existing information resources on our website such as:
- phoning or emailing us for guidance
- seeking assistance from a regulatory affairs or GMP consultant.
Requesting a meeting
GMP pre-submission meetings are generally held by teleconference or video conference, unless there is a demonstrated need to meet in person at TGA offices.
To request a meeting, complete the meeting request form at least two weeks (and no more than two months) before the proposed meeting date and send to the relevant contact:
- For GMP licensing and certification (LI/CE) applications: GMP@health.gov.au
- For GMP clearance (CL) applications: GMPClearance@health.gov.au
Responding to meeting requests
We will review meeting requests and advise whether a meeting is appropriate. In some cases, meetings may be considered unnecessary and a written response may be provided.
TGA will send a meeting invitation to your nominated contacts. Pre-submission meetings are generally scheduled up to 1 hour, unless otherwise agreed.
Any additional information to be used or referred to during the meeting (presentations etc.) must be submitted electronically at least one week prior to the scheduled meeting date.
We may reschedule or cancel a planned meeting where:
- Supporting information and documentation indicated in the meeting request form are not provided at least one week prior to the meeting date
- insufficient information is available to allow for meaningful discussion
During the meeting
- Presentations should be concise and focussed around the complexity or issue requiring guidance.
- Meetings must not be audio or video recorded.
- All participants should take clear notes of relevant key points, agreements, clarifications and action items.
- Where further advice is required, this should be identified during the meeting, including whether follow‑up is needed.
After the meeting
Unless otherwise agreed, the meeting requestor will generally provide a summary of the meeting to the TGA in writing within 1 week. The TGA will review the summary and will provide written feedback and confirmation of key points via email, normally within two weeks of the meeting.
When submitting your GMP application, please reference the GMP pre‑submission meeting you have had. This helps link your application to the meeting discussion for background context.