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Japan, drug registration

Yakuji Nippo, Ltd. (1991). Drug Registration Requirements in Japan. Yakuji Nippo, Ltd., Tokyo, Japan. [Pg.98]

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]

The guidelines (Notification No. 30 of the PAB in 1994) conform to the ICH guidelines on stability testing of new drug substances and new products for a registration application within the 3 arecis of the European Community (EC), Japan and the United States. The results of stability testing conducted in accordance with the tripartite stability guidelines can be used as attached data in Japan. [Pg.291]


See other pages where Japan, drug registration is mentioned: [Pg.322]    [Pg.332]    [Pg.331]    [Pg.341]    [Pg.100]    [Pg.7]    [Pg.83]    [Pg.88]    [Pg.352]    [Pg.741]    [Pg.12]    [Pg.333]    [Pg.31]    [Pg.147]    [Pg.342]    [Pg.17]    [Pg.74]    [Pg.240]    [Pg.299]    [Pg.247]    [Pg.475]    [Pg.193]    [Pg.558]    [Pg.30]    [Pg.66]    [Pg.108]    [Pg.21]    [Pg.348]    [Pg.332]    [Pg.346]    [Pg.350]    [Pg.1090]    [Pg.8]    [Pg.1407]    [Pg.1685]    [Pg.1685]    [Pg.1789]    [Pg.1941]    [Pg.2771]    [Pg.134]    [Pg.2912]   
See also in sourсe #XX -- [ Pg.100 ]

See also in sourсe #XX -- [ Pg.88 ]




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