News Japan scraping rule requiring testing of new drugs on Japanese

[thomas]

No more pharmaceutical exceptionality: Japan plans to ease regulations on clinical trials for new drugs developed overseas, scrapping the rule that drugs' safety must be tested on Japanese people before they can be launched in the domestic market. The move is intended to tackle the issue of "drug loss," in which some 70 per cent 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.

Before a drug can be marketed in Japan, it must undergo three phases of clinical trials. In Phase 1, the drug is administered to a small number of healthy people to confirm its safety. In Phase 2, it is prescribed to a small number of patients to determine efficacy and side effects. Phase 3 involves a large number of patients in countries around the world. The first and second phases of trials are often conducted in the country where the pharmaceutical company developed the new drug. Japan, however, in principle requires additional testing on Japanese people before proceeding to the third phase. The Ministry of Health, Labor and Welfare says this is intended to ensure safety for people living under the conditions found in Japan. However, similar rules are rarely found in other countries. This additional rule has resulted in serious drug loss or "drug lag," preventing or delaying the approval in Japan of drugs that are already used overseas.

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Japan to scrap rule requiring testing of new drugs on Japanese

Dropping slow process in early clinical trials would make medicines available sooner

asia.nikkei.com