Consultation: Provisions to Regularise the Technical Master File (TMFs) and Type II Plasma Master File (PMFs) Processes

Feedback updated 15 Jan 2026

We asked

We invited feedback on proposed amendments to strengthen the legislative framework for Technical Master Files (TMFs) for blood and blood components, and Plasma Master Files (PMFs) for Type II plasma-derived products. The key elements of the proposal included:

Move the exemption from Schedule 5 to Schedule 5A of the Regulations and add specific conditions to regularise existing processes.
Consequential changes that include partial redrafting of the Therapeutic Goods (Manufacturing Principles) Determination 2020 to remove current TMF and Type II PMF references to align with the new regulatory framework.
Insert a new prescribed fee into Schedule 9 of the Regulations.

You said

We received submissions from manufacturers and industry organisations.

There was overall support for the proposed amendments to strengthen the legislative framework for TMFs for blood and blood components, and PMFs for Type II plasma-derived products.

Key considerations

All respondents endorsed the proposals to strengthen the legislative framework and regularise existing requirements to submit annual TMF and Type II PMF updates and to collect the associated evaluation fee, citing it as a positive development.
All respondents expect minimal operational impact, citing that the evaluation process and fee structure will largely remain unchanged, and that the proposed amendments reflect current routine practice.
Broad support emerged for the consequential changes to the Manufacturing Principles (the Determination), recognising these updates will align the Determination with the new regulatory framework. However, several respondents requested further clarification on whether these updates would impact current GMP licensing status and recommended that the TGA define and confirm that existing GMP licences will not be affected, to provide certainty for manufacturers.
Stakeholders recommended that the TGA update its website and related guidance materials to facilitate implementation, industry understanding and compliance.

We did

We now intend to amend the legislation to strengthen the regulatory framework for TMFs and Type II PMFs as proposed in the consultation. In particular, we will:

Amend the legislation to regularise TMF and Type II PMF evaluation processes and fees.
Work with industry representatives to develop comprehensive guidance to support a smooth and effective transition.
Publish individual submissions in line with respondent consent from the consultation.

For further questions, please contact TGA.scientific@health.gov.au.

Published responses

View submitted responses where consent has been given to publish the response.

Overview

The Therapeutic Goods Administration (TGA) is seeking industry feedback on proposed amendments to strengthen the legislative framework for Technical Master Files (TMFs) for blood and blood components, and Plasma Master Files (PMFs) for Type II plasma-derived products.

The proposed changes aim to clarify regulatory requirements, reinforce existing practices, and ensure the legislation reflects the original policy intent. Your input is essential to help ensure the proposed changes are practical, effective, and aligned with industry needs.

The closing date for this consultation is 5.00pm AEST on 11 NOVEMBER 2025. All submissions received by this deadline will be considered by the TGA.

Why your views matter

Since approximately 2001, the TGA has required manufacturers of blood and blood components, and those involved in the fractionation and export of plasma, to prepare and submit TMFs and PMFs for evaluation on both an initial and annual basis:

Technical Master Files (TMFs): submitted by manufacturers of blood and blood components that demonstrates compliance with standards and report any manufacturing changes.
Type 2 Plasma Master Files (PMFs): submitted by the GMP licence holder for imported plasma used in fractionation (not supplied in Australia) to ensure it does not pose a contamination risk to Australian plasma products.

The TGA has reviewed the existing legislative framework and has come to the view that the therapeutic goods legislation either does not, or does not clearly, require the submission of initial and annual updates for TMFs and Type II PMFs, nor the collection of fees for the evaluation of TMFs and Type II PMFs.

Here, we propose to regularise existing evaluation processes for TMFs and Type II PMFs, including in relation to the collection of a fee for those evaluations. These changes will:

regularise existing processes for TMFs and Type II PMFs (aligned with the original policy intent)
enhance regulatory clarity, and
provide a clear basis to support the fees collected.

Consultation paper

Provisions to Regularise the Technical Master File (TMFs) and Type II Plasma Master File (PMFs) Processes

What happens next

Written submissions will help the TGA assess the proposed changes outlined in this consultation paper. Your input is essential to building a comprehensive understanding of the potential impacts of these proposed changes. We will carefully assess any regulatory burden in relation to the expected benefits.

After reviewing all feedback, the TGA will advise the Government on updates to the legislation to support the proposed amendments.

Following the consultation period, the Therapeutic Goods Administration (TGA) will:

consider all submissions received.
publish a summary of responses and the final decision on the TGA website.
finalise drafting of amendments.
seek approval for legislative changes.
communicate implementation timelines and transitional arrangements.

We appreciate your contribution and look forward to your insights.

Public submissions are published on the TGA website. for further details, refer to the section on Privacy Collection Notice in this consultation.

Audiences

Biologicals
Businesses
Commonwealth agencies
General public
Health professionals
Health staff
HPRG (TGA) Staff
Industry
Manufacturer
Manufacturers
Non-government organisations
Sponsor
Sponsors
State government agencies

Interests

Fees and payments
Manufacturing
Regulatory policy
Safety