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International Conference regulatory guidelines

In June 2004 the Australian Regulatory Guidelines for Prescription Medicines (ARGPM) were issued by the TGA to replace the AGRDl. Under the ARGPM the format for registration applications in Australia is the Common Technical Document (CTD) developed through the International Conference on Harmonisation (ICH). [Pg.656]

The International Conference on Harmonization of Technical Requirements for the Registration for Pharmaceuticals for Human Use is a tripartite initiative by the EU, Japan, and the United States to harmonize the regulatory guidelines in these three regions in order to reduce duplication and redundancy in the development and registration of new drugs. [Pg.863]

See other pages where International Conference regulatory guidelines is mentioned: [Pg.535]    [Pg.37]    [Pg.5]    [Pg.101]    [Pg.83]    [Pg.773]    [Pg.850]    [Pg.20]    [Pg.105]    [Pg.293]    [Pg.4]    [Pg.155]    [Pg.222]    [Pg.380]    [Pg.193]    [Pg.360]    [Pg.4]    [Pg.260]    [Pg.311]    [Pg.552]    [Pg.89]    [Pg.54]    [Pg.93]    [Pg.642]    [Pg.750]    [Pg.8]    [Pg.10]    [Pg.494]    [Pg.432]    [Pg.181]    [Pg.48]    [Pg.126]    [Pg.208]    [Pg.719]    [Pg.734]    [Pg.1090]    [Pg.8]    [Pg.3]    [Pg.24]    [Pg.702]    [Pg.736]    [Pg.513]    [Pg.56]    [Pg.124]    [Pg.302]    [Pg.569]    [Pg.1407]    [Pg.1789]   
See also in sourсe #XX -- [ Pg.448 ]

See also in sourсe #XX -- [ Pg.463 ]



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