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

While the consultation is open you can make a submission at our consultation hub.

We review the submissions. After that the submissions and our decision will be available on the same consultation hub.

Overview

The Therapeutic Goods Administration (TGA) is inviting industry feedback on proposed amendments to strengthen the legal framework governing:

• Technical Master Files (TMFs) for blood and blood components, and
• Plasma Master Files (PMFs) for Type II plasma-derived products.

These reforms aim to:

• clarify regulatory requirements,
• reinforce existing practices, and
• ensure legislation aligns with the original policy intent.

Provisions to regularise the Technical Master File (TMFs) and Type II Plasma Master File (PMFs) processes

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, or the collection of fees for the evaluation of TMFs and Type II PMFs. As such, we are seeking stakeholder input to inform our considerations for future regulatory reform.

Submissions must be received by 5.00pm on 11 November 2025.

Consultation document

The consultation is available at Consultation: Provisions to regularise the Technical Master File (TMFs) and Type II Plasma Master File (PMFs) processes.

For enquiries, please contact tga.scientific@health.gov.au.