no Orphan Drug policy

Special Access Scheme (SAS) for unapproved drugs

provision for reduction of fees under cost recovery for products used to treat rare but clinically significant conditions for which there is only a limited market

no Orphan Drug policy

EDRP/IND provides access to unapproved drugs

SR&ED Tax Incentive Program would support R&D in the area of Orphan Drugs

provision for reduction of fees for small market drugs under cost recovery

process patents granted for biotechnology products

Conditional Approvals proposed under New Licensing Framework

Orphan Drug Program

designation granted based on prevalence of disease in the population of less than 0.05%.

grant program for R&D for manufacturers and importers of orphan drugs

guidance and advice available to industry on both R&D and NDA application procedures

tax incentives granted to manufacturers doing R&D on orphan drugs

NDA for orphan drugs are given priority review

  if drug is marketed, a portion of profits in excess of 100 million yen must be paid to the government

Orphan Drug Act (January 4, 1983)

designation granted based on prevalence of disease in the population of less than 200,000 people (approximately 0.1%) OR no reasonable expectation of profitability.

protocol assistance to design research protocols

tax credits for clinical research

market exclusivity

funding grants for clinical research to support development

penalty for intentionally false statement of orphan status

Parallel Track Program and Treatment INDs provide access to unapproved drugs

process patents granted for biotechnology products

Accelerated Approvals