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 Medical Products.
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 medical products
The Terms of Reference (ToR) of the Centre for the period 2026-2030 include:
- To support the WHO by performing laboratory testing for the quality assurance of medical products, and to support the development of test procedures for detecting substandard and falsified medical products.
- To support the WHO in strengthening institutional capacity of National Regulatory Authorities associated with the regulation of medical products, specifically for laboratory quality assurance.
- To support the WHO through the provision of technical advice which may inform its activities in influenza and SARS-CoV-2 vaccine virus selection.
- To support the WHO in the development of international written standards (including International Pharmacopoeia monographs) and guidance documents for medical products.
- To provide input to the WHO that may inform its activities in international measurement standards and reference reagents for vaccines, biological medicines and chemical reference standards.