Good clinical practice Australia

Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95). Annotated with TGA comments. Therapeutic Goods Administration [TGA] (Australia), Commonwealth Department of Health and Aged Care. The TGA has adopted CPMP/ICH/ 135/95 in principle but has recognised that some elements are, by necessity, overridden by the National Statement (and therefore not adopted) and that others require explanation in terms of local regulatory requirements , July 2000. http //www.health.gov.au/tga/docs/html/ ichl3595.htm. 

General Clinical trials of products approved for registration are not covered by the above categories and are considered to be subject to the Therapeutic Goods Administration s Guidelines for Good Clinical Research Practice (GCRP) in Australia.55... 

Guidelines for Good Clinical Research Practice in Australia (www.tga.gov.au/docs/pdf/euguide/ich/ichl3595.pdf). 

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