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

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