Compassionate drug use to debut in Japan

The Study Group on Rapid Supply of Effective and Safe Drugs within the Japanese Ministry of Health, Labor and Welfare agreed at its meeting this month to introduce a compassionate use system of unapproved drugs, which is already in use in Europe and the USA. If introduced, the Ministry will allow manufacturers, importers and physicians to formally import unapproved drugs when they need to be used because there are no alternatives and where there is a case of a life-threatening disease.

However, regarding the range of unapproved medicines, Hatuso Aoki, a a member of the group and president of the Japan Pharmaceutical Manufacturers Association, raised the point that drug manufacturers cannot ensure quality of medicinal products without filing New Drug Applications and providing information on safety and efficacy after Phase III clinical trials.