Factsheets

Safety and Efficacy of Blood and Blood Products In Australia

Who is responsible for regulating the safety and efficacy of blood and blood products in Australia?

The responsibility of producing safe and effective blood products rests with the manufacturers of those products. However, governments have appointed a regulator to make sure that manufacturers uphold the standards required by Australia.

The Therapeutic Goods Administration (TGA) has primary responsibility for regulation of products and establishing production standards for the Australian blood sector.

TGA is responsible for:

regulating the sector in terms of the efficacy, safety and quality of
blood and blood products under the Therapeutic Goods Act 1989;
auditing of good manufacturing practice;
product recalls;
modifications to safety standards; and
issuing directives such as donor deferrals.=

Blood and blood products, whether domestic or imported, all have to meet stringent guidelines set out by the TGA. All products are regulated at the highest level regardless of their source. The TGA is world-class in regulatory matters and has strong relationships with international agencies such as the Unites States Food and Drug Administration. This ensures the safety and efficacy of all imported products and that TGA continues to hold itself to world class standards in the blood sector.

How is the safety and efficacy of blood and blood products ensured in Australia?

There are a number of standards and principles employed in Australia to ensure the quality, safety and efficacy of blood and blood products in Australia. These include pre-market assessments, testing and auditing measures for blood and blood products and manufacturers.

Donor Deferrals

For blood and blood products it is essential that the starting material is of the highest quality. This means the donations received. There are a number of ways to assure the quality of the source material such as donor deferrals. This means not allowing blood donation from some individuals until such time as they are deemed fit to donate. For example blood donors who visit or who have lived in areas where malaria is endemic are deferred from donating blood for a considerable time period after they return. This is to ensure that any malaria infection picked up while overseas is not transmitted to patients.

Screening and Testing

As the collector of blood donations in Australia, under regulation of the TGA, the Australian Red Cross Blood Service (ARCBS) is required to ensure all applicants for blood donation are screened through a series of questions. Further to this, the ARCBS also test each unit of blood donated for diseases such as hepatitis and HIV and other blood-borne pathogens.

Licensing

All manufacturers are subject to the Australian Code of Good Manufacturing Practice - Human Blood and Tissues and are required to have licences, which are issued by the TGA. TGA conducts audits of manufacturers to ensure compliance.

Adverse Reactions

The TGA has an Adverse Drug Reaction Unit which monitors the blood sector through feedback received.

Tracking systems

Track and trace mechanisms are also in operation which ensures that all donations can be tracked from entry point in the system to the final product and recipient. This is also true for all imported blood products.

Recalls

Product recalls is another measure to ensure the safety and quality of products and is allowable through the track and trace measures. For example, products have been recalled in the past due to insufficient labeling standards. For further information visit www.tga.gov.au

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Factsheets

Safety and Efficacy of Blood and Blood Products In Australia