Grant of Aid
The Nationa lInstitute of Biochemical Innovation grants aid to orphan drugsponsors to helppay for study costs required for development. Direct expensesrequired in research from designation to application forapproval are entitled tothis aid, and maximum amount of the aid is half ofthat amount. Also when apostmarketing clinical study is required for approval of an HIV remedy, cost ofthis clinicalstudy is also eligible for this aid.
After receiving application for the aid from a sponsor company, the NationalInstitute of Biomedical Innovation studies contents, objectives, cost, and studyprotocols,etc., and determines the monetary amount of subsidy.
After receiving the aid, a sponsor can be asked to pay a proportion of theprofit obtained from anorphan drug to the National Institute of BiomedicalInnovation (the amount oftotal payment will not exceed the amount of aidgranted). The National Institute of Biomedical Innovation reallocates thiscapital to promote development of other orphandrugs.
This aid also is now increasingly recognized as a specific subsidiary of Small Business Innovation Research (SBIR) based on the Law for Facilitating the Creation of New Business. Small businesses that receive this aid are qualifiedto receive preferential measures (includingan increased guarantee of debt) tofacilitate marketing of the research outcome as determined by the SmallBusiness Credit Insurance Corporation Law.
Annual Schedule of Granting Aids| 1.Briefing session | Late April |
| 2.Submission of application form for aid* | Mid-May |
| 3.Hearing | May to June |
| 4.Determination notice about the grant (for firstapplication in the fiscal year) |
July |
| 5.Acceptance of an approximate bill and payment of thefirst credit | Late July |
| 6.On-site inspection and progress confirmation | October to November |
| 7.Application for changes in the research plan (acceptanceof new application from the middle of fiscal year) |
December |
| 8.Hearing and on-site inspection (new applications inthe middle of fiscal year) |
December to January |
| 9.Determination notice about the grant (forapplication in the middle of the fiscal year) |
January |
| 10.Acceptance of an approximate bill and payment of thesecond credit | February |
| 11.Submission of outcome report | By March 31 |
| 12.Determination and refund notice | Late April |