Compassionate drug use proposed in Japan

The compassionate use system for unapproved drugs, which has already been introduced into Europe and the USA, has been proposed by the Japanese Ministry of Health, Labor and Welfare, during the Ministry's study group on rapid supply of effective and safe drugs held earlier this month.

Although unapproved drugs are now available in Japan through private imports by physicians and patients, their authorized compassionate use will allow pharmaceutical manufacturers and importers to officially bring in such medicines, resulting in ensuring safety, quality and efficacy of the products.

The Ministry plans to allow manufacturers, importers, etc, to manufacture, import and market unapproved drugs when these need to be used because there are no alternative medicines and where there is a case of a life-threatening disease.