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Orphan drugs in Japan

Public policy on orphan drugs in Japan

On 1 October 1993, the Japanese government revised the pharmaceutical law by introducing special provisions relative to research and development of orphan drugs.

According to these new provisions, orphan drug status can be granted to a drug, provided it fulfills the following two criteria :

There is a significant proportion of multinational companies, including Japanese companies that market orphan drugs. Yet small and medium companies account for the most important part of suppliers.

As in the USA, the Japanese orphan drugs system offered new opportunities both for multinational and small-size and medium-size companies. On the contrary, public institutes and universities, and biotechnology companies are less active than in the USA.

Limit of incidence for a rare condition : 4 / 10 000

Orphan drugs labelling and legal status

The orphan drug status is granted by the Ministry of Health, Labour and Welfare (MHLW). Scientific examination is in the hands of a subcommittee of the Medicinal Products Committee. Conclusions are sent to a special committee.

In order to recieve orphan designation, the sponsors must submit the following data to the Authorities :

The orphan drug status that has been granted may be withdrawn if the conditions of the licence are no longer fulfilled.

Incentives to orphan drugs providers in term of R&D, intellectual property and marketing

The Japanese government's support for research and development orphan drugs can be found at two levels :

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