Regulation of blood

4 July 2016

Blood, blood components and plasma derivatives are regulated under the Therapeutic Goods Act 1989. Plasma derivatives are prescription medicines subject to full regulation under provisions requiring standards, licensing of manufacture and inclusion in the Australian Register of Therapeutic Goods (ARTG) after review of manufacturing, pre-clinical and clinical data. Under the Act 'blood' means whole blood extracted from human donors and 'blood components' means therapeutic components that have been manufactured from blood (including red cells, white cells, progenitor cells, platelets and plasma). 'Blood components' does not include products derived through fractionation of plasma.

Some blood and blood components are exempt from TGA oversight including blood and blood components that are:

  • collected by a medical practitioner in the course of medical treatment and for the purposes of diagnosis of, or testing for, a medical condition
  • manufactured by a medical practitioner for therapeutic application to a particular patient under the practitioner's care
  • manufactured by a blood collection center for a medical practitioner for therapeutic application to a particular patient under the practitioner's care.

These exemptions are generally considered to cover autologous and directed donations under the supervision of a medical practitioner where the blood or blood components are immediately supplied for a named patient on a pre-determined basis. Where storage occurs and supervision of that storage by the same medical practitioner cannot be guaranteed, the blood or blood components may not be exempt.

Therapeutic Goods (Manufacturing Principles) Determination No 1 of 2013 determines that a manufacturer of blood or blood components (which are not exempt) must obtain a licence under Part 3-3 Section 36(1) of the Act. To obtain a licence for the manufacture, blood and blood components and plasma must be manufactured in compliance with the Australian Code of Good Manufacturing Practice for human blood and blood components, human tissues and human cellular therapy products 2013 and in a manner consistent with the relevant Technical Master file lodged by the manufacturer.

'Technical Master Files' are compilations of scientific data provided by the manufacturer which includes a description of the steps in manufacture consistent with the document entitled 'Guideline for the preparation of Technical Master Files for blood, blood components and haematopoietic progenitor cells'. The detailed technical and scientific information must satisfy the TGA that the blood or blood components are manufactured according to the standards described in Therapeutic Goods Order No. 88 - Standards for donor selection, testing and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products, Therapeutic Goods Order No. 81 - Standards for Blood and Blood Components and that haematopoietic progenitor cells derived from cord blood are manufactured according to the standards described in Therapeutic Goods Order 75 - Standards for Haematopoietic Progenitor Cells Derived from Cord Blood.

Therapeutic Goods Order No. 88 - Standards for donor selection, testing and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products, outlines the minimum technical requirements, particularly in relation to donor selection, donor testing, and the collection and manufacture of therapeutic goods that are human blood, blood components, with which these products must comply to minimise the risk that these products may transmit infectious diseases.

Therapeutic Goods Order No. 81 - Standards for Blood and Blood Components, states blood and blood components must meet the requirements of the Council of Europe document 'Guide to the preparation, use and quality assurance of blood components' 14th edition and must only be manufactured from blood that tests negative for HIV-1 and HCV using Nucleic Acid Amplification Technology.

Therapeutic Goods Order 75 - Standards for Haematopoietic Progenitor Cells Derived from Cord Blood states that haematopoietic progenitor cells derived from cord blood must meet the requirements of the document entitled 'International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection, and Release' Third edition, dated December 2006, published by the Foundation for the Accreditation of Cellular Therapy and NetCord and must be appropriately screened for HIV and HCV.

The laboratories that carry out viral and serological testing associated with the collection of blood and blood components are also required to comply with the Code of Good Manufacturing Practice for Human Blood and Tissues.