World Health Organization collaborating centres
The TGA Laboratories is designated by the World Health Organization (WHO) as:
- a WHO Collaborating Centre for Drug Quality Assurance, and
- a WHO Collaborating Centre for Quality Assurance of Vaccines and other Biologicals
These Centres form part of the collaborative network set up by WHO in support of its policies and programs. Designation is based on the alignment of TGAL activities and expertise with WHO aims and objectives. Each Centre provides a four-year activity plan to the WHO and submits progress reports annually.
WHO Collaborating Centre for Drug Quality Assurance
Current activities of the Collaborating Centre for Drug Quality Assurance include the following:
- Research in the development and validation of test methods for drug products.
- Quality control testing of drug products.
- Collaboration in the training of laboratory personnel in the validation and application of analytical procedures in the quality control of drugs.
- Collaboration in the training of GMP auditors for countries of the Western Pacific Region.
- Provision of expert advice to National Control Authorities on the establishment and management of programs directed to regulation of drug quality control and licensing of drug manufacturers.
- Support for the programs of the International Pharmacopoeia.
WHO Collaborating Centre for Quality Assurance of vaccines and other biologicals
The objective of the Centre is to ensure the consistent safety and quality of vaccines and biologicals used in and exported from Australia and to assist in promoting the capacity for regulatory quality assurance by national regulatory authorities for vaccines used in the Western Pacific Region. The terms of reference by which TGAL fulfils its role a WHO Collaborating Centre are set out below:
- To provide consultancy in the field of quality assurance of vaccines and other biologicals.
- To develop or maintain appropriate training curricula and materials on quality assurance of vaccines and other biologicals, with reference to the essential functions of national regulatory authorities outlined by WHO.
- To conduct training for appropriately qualified staff of national regulatory authorities, and where pertinent quality assurance staff of vaccine production institutes, from countries and areas in the rest of the world, depending on the needs and priorities developed through consultation between the WHO Regional Office for the Western Pacific (WPRO) and WHO headquarters.
- To participate fully in exchange of information and expertise with regional and global networks of national regulatory control authorities.
- To perform appropriate testing of vaccine quality as required.
- To contribute in the development and review of written standards for biological products, including those products based on genetic manipulation and vaccines.