Japan to scrap rule requiring testing of new drugs on Japanese
Dropping slow process in early clinical trials would make medicines available sooner
Nikkei -- Nov 14
Japan will ease regulations on clinical trials for new drugs developed overseas, Nikkei has learned, scrapping the rule that in principle drugs' safety must be tested on Japanese before they can be launched in the domestic market.
The move is intended to tackle the issue of "drug loss," in which some 70% of new drugs approved in Europe and the U.S. do not win approval for use in Japan, partly due to the strict regulations. The policy change is expected to lower barriers for foreign pharmaceutical companies, making their new drugs accessible in Japan as soon as possible. ...continue reading
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Japan to scrap rule requiring testing of new drugs on Japanese
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Japan will ease regulations on clinical trials for new drugs developed overseas, Nikkei has learned, scrapping the rule that in principle drugs' safety must be tested on Japanese before they can be launched in the domestic market.
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