Supplying therapeutic goods that contain human plasma and plasma derivatives

Australia is a signatory to the World Health Organization (WHO) policy that encourages countries to achieve self-sufficiency in the supply of goods derived from human blood. The aim of this policy is for therapeutic goods containing human blood or plasma for supply in Australia to be manufactured from blood or plasma collected from Australian donors.

The National Blood Authority (NBA) manages the supply of these products.

We evaluate therapeutic goods derived from human blood or plasma under relevant Australian regulatory requirements and recognised international standards and guidelines, to minimise the risk of transmitting infectious diseases through their use.

The regulatory framework supports the safe supply of human blood and plasma-derived therapeutic goods through controls that manage risks associated with donor-derived materials, including infectious disease transmission and variability in plasma quality.

We have adopted the European Medicines Agency (EMA) guideline - Guideline on plasma-derived medicinal products (EMA/CHMP/BWP/706271/2010).

This guideline:

• outlines the quality and control measures expected of a medicinal product that is manufactured from human plasma
• is used as guide to assess these products.

Additional information and guidance for adventitious agent safety of therapeutic goods is available in the guidance Demonstrating the safety of adventitious agents.

Medicines derived from human plasma

The plasma used as a raw material in the manufacture of medicines derived from human plasma must comply with either:

• the European Pharmacopoeia (Ph. Eur.) monograph ‘Human Plasma for Fractionation’ (0853)
• the British Pharmacopoeia (BP) monograph 'Human Plasma for Fractionation', which are Standards under subs. 3(1) of the Act.

The United States Pharmacopeia-National Formulary (USP-NF) monograph 'Plasma protein fraction'

The United States Pharmacopeia-National Formulary (USP-NF) monograph 'Plasma protein fraction' is not a Standard because it is exempted under the Therapeutic Goods (Exempt Monographs) Determination 2021, thereby excluding the USP-NF as a Standard for these products.

For this reason, the Monographs of the USP-NF cannot be used for the following medicines derived from human plasma:

• Antithrombin Ill Human
• Factor IX Complex
• Plasma Protein Fraction

Plasma used for fractionation

In addition to the requirements of the applicable monograph, plasma used for fractionation must comply with the:

• Therapeutic Goods Order No. 108 – Standard for Human Cell and Tissue Products – Donor Screening Requirements (TGO 108), including the donor screening and exclusion criteria.

Standard for Human Albumin

The standard for human albumin accepted by the TGA is defined by the Therapeutic Goods (Standard for Human Albumin) (TGO 111) order 2022.

TGO 111 provides that the requirements for human albumin are those specified in an applicable individual or general monograph in the British Pharmacopoeia (BP) or the European Pharmacopoeia (Ph. Eur.), as interpreted in accordance with the General Notices section of the relevant Pharmacopoeia.

A Plasma Master File (PMF) is a document which play a central role in ensuring the quality of plasma used in the production of plasma derived products such as clotting factors and immunoglobulins.

What is a Plasma Master File and why is it required

A PMF is a stand-alone document that records technical and scientific information relating to the quality aspects of human plasma used as a raw material for the manufacture of therapeutic derivatives.

The PMF includes information on:

• the source of the plasma
• the location(s) where the plasma was collected
• the screening process for donors
• the tests used to screen donated blood and plasma
• the results of these testing procedures (epidemiology data).

A PMF is required to support applications for inclusion on the Australian Register of Therapeutic Goods (ARTG) where the therapeutic good is derived from, or contains, human plasma or plasma derivatives.  

Types of Plasma Master Files

For administrative purposes, we group PMFs into two categories:

• Type I PMFs: support plasma-derived products or products containing plasma derivatives that are supplied in Australia. A Type I PMF forms part of the quality information required for the registration and ongoing supply of those products on the Australian Register of Therapeutic Goods (ARTG).
• Type II PMFs: support the importation of plasma for fractionation into Australia, which is processed or fractionated by a licensed manufacturer, and is exported rather than supplied in Australia.