The TGA uses internationally harmonised manufacturing standards to allow manufacturers to OPERATE in an international environment. The TGA maintains its GMP standards in line with updates issued through the PIC/S. Regular updates are necessary to maintain MUTUAL confidence with regulators overseas and to promote quality assurance of inspections and HARMONISATION of technical standards and procedures with international inspection standards for the production and testing of medicinal products.

Australian manufacturers benefit from REDUCED regulatory burden where the TGA is able to adopt harmonised international standards and establish mutual recognition agreements and cooperation arrangements with COMPARABLE overseas regulatory authorities.

The TGA uses internationally harmonised manufacturing standards to allow manufacturers to operate in an international environment. The TGA maintains its GMP standards in line with updates issued through the PIC/S. Regular updates are necessary to maintain mutual confidence with regulators overseas and to promote quality assurance of inspections and harmonisation of technical standards and procedures with international inspection standards for the production and testing of medicinal products.

Australian manufacturers benefit from reduced regulatory burden where the TGA is able to adopt harmonised international standards and establish mutual recognition agreements and cooperation arrangements with comparable overseas regulatory authorities.