[From ethnic difference to ethnic similarity].
It becomes the important issue for the medical supplies administration to solve the drug lag in our country. As means to overcome both the slow speed and high cost of clinical trial for new drug application in Japan, it seems useful to carry out clinical development simultaneously in East Asia countries such as China, Korea and Taiwan where it is thought that each country has similar ethnicity one another. When conducting simultaneous development with the same protocol in plural countries, it should be avoided that side effect develops abusively. In addition, both the effectiveness and safety expected after marketing should be secured in each country by a recommended amount of medicine for usage provided by simultaneous development between many countries. It is necessary for ethnic similarity to be shown so that development between the many countries in the same dosage is permitted at least. It is expected that the possibility of mutual utilization of clinical trial data of China, Korea and Japan will be shown by pharmacokinetics and pharmacodynamics examinations based on clinical test data of these countries by the Scientific Research funded by MHLW. On the other hand, it seems that it is meaningful and significant to examine the similarity at the gene level from various points of view. In order to give grounds for the validity of carrying out clinical trial in the same protocol in East Asia countries, it may be useful to examine genetic diversity of East Asia countries with plural heredity anthropological techniques such as heredity distance, and compare degree of the genetic diversity between the races of East Asia countries and that of other regions, for example, West Europe countries which have been recognized as one clinical trial field.
Nakajima
Kazuhiko
K
Drug Evaluation Committee, Japan Pharmaceutical Manufactures Associations, Tokyo, Japan. nakajima.kazuhiko.bj@daiichisankyo.co.jp
D000883:Anthropology / Q000379:methods; D002986:Clinical Trials as Topic; D015195:Drug Design; D054796:Drug Dosage Calculations; D005006:Ethnicity; D005202:Asia, Eastern; D014644:Genetic Variation; D006801:Humans; D007391:International Cooperation