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Regulatory authorities international agencies

When MRLs are set under Japanese law, the Japanese authorities will consider the Codex MRLs for international harmonization. However, Japan has set original food consumption amounts and GAPs. In this respect, the Japanese regulatory agency retains the rights to establish original values for the MRLs for each commodity based on toxicological exposure assessment. [Pg.40]

Russell KB, Bremer M. New Drug Approval in Japan. Waltham, MA PAREXEL International, 2002. The authors provide a thorough analysis of Japan s reorganized regulatory agency structure, its streamlined NDA process, and its rapidly evolving policies toward the acceptance of foreign clinical data. [Pg.134]

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International agencies

International regulatory authorities

Regulatory agencies

Regulatory authorities

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