The Laboratories Branch maintains important links with other National Regulatory Authorities and organisations. We participate in international collaborative studies and in the calibration of reference materials for use as standardised test controls and also provide scientific advice and specialised training in laboratory techniques to other National Regulatory Agencies.
Our branch is responsible for the batch certification scheme (Batch Certificate of a Pharmaceutical Product - BCPP) for batches of biological products being exported from Australian manufacturers to overseas markets.
Development of technical standards
As an integral part of the regulatory process, we are involved in the development of technical standards for therapeutic goods, at both national and international levels. These are often in the form of guidelines for industry, Australian Standards, ISO standards, pharmacopoeial monographs or input to pharmacopoeial committees. We actively cooperate with other National Regulatory Authorities, international committees and international standard setting organisations including:
- Standards Australia;
- International Organisation for Standardisation (ISO);
- British Pharmacopoeia (BP) Commission;
- European Directorate for the Quality of Medicines & Healthcare (EDQM)
- European Pharmacopoeia (PhEur) Commission;
- European network of Official Medicines Control Laboratories (OMCLs);
- European Medicines Agency (EMA);
- United States Pharmacopeia (USP) Convention; and
- World Health Organization (WHO).
The Pacific Medicines Testing Program
The Pacific Medicines Testing Program was announced on 8 September 2017 by the Prime Minister at the Pacific Islands Forum in Apia, Samoa, to enhance regional health security. The Australian government, through the TGA and the Department of Foreign Affairs and Trade, are providing a program to provide Pacific Island countries and Timor-Leste access to Australian laboratory testing for therapeutic goods quality assurance. Therapeutic goods are tested by our Laboratories Branch with funding provided by DFAT.
The Program focuses on testing of medicines for non-communicable diseases (such as medicines for heart disease and diabetes), as well as antibiotics and COVID-19 products (such as face masks). Participating countries can also send therapeutic goods to TGA when there is a problem or a complaint. The testing services provided by TGA is at no cost to participating countries. Most of the therapeutic goods are tested during planned testing campaigns. The first campaign commenced in March 2018. There are 13 countries participating in the Program: Federated States of Micronesia, Fiji, Kiribati, the Marshall Islands, Nauru, Palau, Papua New Guinea, Samoa, Solomon Islands, Timor-Leste, Tonga, Tuvalu, and Vanuatu. Further information on the testing results is available under the Laboratories testing section in our Annual performance statistics reports.
World Health Organization collaborating centres
The TGA laboratories are designated by the World Health Organization (WHO) as a:
- WHO Collaborating Centre for Drug Quality Assurance; and
- WHO Collaborating Centre for Quality Assurance of Vaccines and other Biologicals
The two WHO collaborating centres form part of the collaborative network set up by WHO in support of its policies and programs. Designation is based on our activities and expertise that align with WHO aims and objectives. Each centre provides a four-year activity plan to the WHO and submits progress reports annually.
More information: WHO collaborating centres
WHO Collaborating Centre for Drug Quality Assurance
The Terms of Reference (ToR) of the Centre for the period 2019-2022 include:
- Provide support to the WHO's programme of the International Pharmacopoeia, including development and validation of test methods for medicines
- Perform quality assurance testing of medicines.
- Provide scientific advice on the quality assurance of medicines.
- In collaboration with WHO, provide training of laboratory personnel in the validation and application of analytical procedures in the quality assurance of medicines.
WHO Collaborating Centre for Quality Assurance of Vaccines and Biological Medicines
The Terms of Reference (ToR) of the Centre for the period 2019-2022 include:
- To support WHO by contributing to strengthening institutional capacity of regulatory authorities through the regional alliance frameworks, associated with vaccines and biological medicines, in the Western Pacific Region or other regions.
- To support WHO by performing laboratory testing for the quality of vaccines and biologicals including in vitro diagnostics to support countries where there is no direct access to local laboratory services.
- To support WHO by providing scientific/technical advice in developing international written standards and guidelines, and influenza vaccine virus selection.
- To support WHO by contributing to the development of WHO's international measurement standards and reference reagents for vaccines and biologicals and global and regional NCL cooperation.