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The TGA has various international agreements and arrangements with other countries and regulatory authorities. Some of these allow us to rely on each other’s Good Manufacturing Practice (GMP) inspection programs. The scope of these agreements, the regulatory authorities covered and how they can be used in applications for GMP Clearances from the TGA is outlined below.
NOTE: before we can accept evidence from another regulatory authority as part of a GMP Clearance application, we assess that regulatory authority’s GMP program and confirm its equivalency to Australia’s GMP requirements.
For more information on the GMP Clearance process, please refer to the GMP Clearance guidance.