Annex Guideline Similar Biological Medicinal Products Containing Biotechnology Derived Proteins Active Substance NON Clinical AND Clinical Issues
TGA (CWLTH) resource. Rules Mate indexes this as part of the Australian compliance corpus. Click through for the regulator's primary source.
https://www.tga.gov.au/resources/resources/international-scientific-guidelines-adopted-australia/annex-guideline-similar-biological-medicinal-products-containing-biotechnology-derived-proteins-active-substance-non-clinical-and-clinical-issues
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