Laboratories Branch: international affiliations

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).

World Health Organization collaborating centres

The TGA laboratories are designated by the World Health Organization (WHO) as a WHO Collaborating Centre for Quality Assurance of Vaccines and other Biologicals.

The WHO collaborating centre forms 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. The centre provides a four-year activity plan to the WHO and submits a progress report annually.

More information: WHO collaborating centres

WHO Collaborating Centre for Quality Assurance of Vaccines and Biological Medicines

The Terms of Reference (ToR) of the Centre for the period 2022-2026 include:

• To support WHO by contributing to strengthening institutional capacity of regulatory authorities through the regional alliance frameworks, associated with vaccines and biological medicines.
• To support WHO by providing technical advice which may inform its WHO’s activities in the development of international written standards and guidance documents, and influenza vaccine virus selection.
• To provide input to WHO that may inform it’s activities in international measurement standards and reference reagents for vaccines and biological medicines.
• To support WHO by performing laboratory testing for the quality of vaccines and biologicals including in vitro diagnostics to support WHO in its work with Member States where there is no direct access to local laboratory services.