Preferential Treatment to Promote Research and Development
The following preferential treatments are entitled to an orphan designatedproduct, as asupport to its research and development from the Ministry ofHealth, Labor and Welfare, the Pharmaceuticals and Medical Devices Agency,and the National Institute of Biochemical Innovation.
Support offered by the Ministry of Health, Labor and Welfare andPharmaceuticals and the Medical Devices Agency
1) Preferentialconsultation for clinical study and priority review
Once orphan designated, the product is prioritized to other medicinalproducts in receiving face-to-face advice and review so it can be available tothe medical front assoon as possible.
2) Extension of reexamination period
A reexamination period is extended for a medicinal product approved as an orphan drug from regular 8 years to maximum 10 years, and for a medicaldevicefrom 4 years to maximum 7 years.
Support Offered by National Institute of Biochemical Innovation
1) Offer subsidy for study cost required for development (grant of aid)
2) Offer guidance and advice on experimental research (guidance and advice)
3) Office administrative service for tax incentives on experimental researchfees (issuance of approval)