Ethnic factors extrinsic

Foreign clinical results are acceptable except in areas where there are immunological and ethnic differences between Japanese and foreigners. The ethnic factors are divided into two components intrinsic factors such as racial factors and physiological differences and extrinsic factors, which include cultural and environmental issues. In these cases, the MHLW may require that some bridging comparative clinical trials be performed with dose ranging protocols. This will enable absorption, distribution, metabolism, and excretion studies to be carried out on Japanese individuals and provide better dosage and indication for the Japanese people. The MHLW also requires that application be accompanied by one year of real-time stability data and that sterility test results be included. 

Table 18.1 Classification of intrinsic and extrinsic ethnic factors (ICH Guidance, 1997)...

Extrinsic ethnic factors that may include environment (e.g., geographic location), use of tobacco, use of alcohol, use of other drugs, and food habits. 

The globalization of pharmaceutical research and development is expected to shorten the time required for product approval and registration, by increasing the number of subjects available for research studies and broadening an investigational product s exposure to ethnic intrinsic factors (genetic and physiological) and extrinsic factors (cultural and environmental). 

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