|About Orphan Drugs|
|What is an orphan drug?||Orphan drugs in Europe|
|Orphan drugs in the United States of America||Orphan drugs in Japan|
|Orphan drugs in Australia||Orphan drugs in Singapore|
|Orphan drugs for Third-World countries||Worlwide Comparison of regulation|
|Clinical trials||Search for a drug|
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
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The orphan drug status that has been granted may be withdrawn if the conditions of the licence are no longer fulfilled.
The Japanese government's support for research and development orphan drugs can be found at two levels :
Orphan drugs benefit from a fast-track Marketing Authorisation procedure. In particular, the law requires priority of evaluation of applications made for indications concerning rare diseases.
In addition to this measure, the Organisation for Pharmaceutical Safety and Research provides pharmaceutical companies launching orphan drugs with a consultation on development protocols and some advice concerning the preparation of approval applications.
The registration validity period, which varies from four to six years for traditional drugs is extended to 10 years for orphan products.
Some government funds, such as the Drug Fund for Side-Effects Relief and Research Promotion, are available.
These funds guarantee financial assistance to cover a proportion of the expenditure devoted to research and development of orphan drugs.
Funding also covers scientific activities and the provision of advice in terms of development, notably concerning clinical trials.
The Japanese authorities reimburse up to 50% of the development costs. This measure costed to Y2bn from 1993 to 1997. The support for individual drugs ranged from Y4m to Y72m per compound, with an average of Y16m.
In addition, a 6% tax reduction for Research and Development expenses is granted, other than those coming from funding grants and within the limit of 10% of company tax.
Companies making profits on sales of orphan drugs must return a proportion of the subsidy granted as a contribution to these funds.
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