Guidance and Advice

When consulted for　research by a sponsor, the National Institute of Biomedical Innovation offers　guidance and advice in cooperation with the Ministry of Health, Labor and　Welfare and the　Pharmaceuticals and Medical Devices Agency.

Consultation services are provided by the　following organizations, depending on the phase as follows. The National Institute of Biomedical　Innovation basically consults after the product is designated as a medicine fora rare disease and until it is applied for marketing approval.

Organization to Consult withDepending on Phase

valuationandLicensingDivision,Pharmaceutical and Food Safety Bureau, Ministry of Health,Labor, and Welfare	Consultation on application for designation (before designation
National Institute of Biomedical Innovation	Consultation on research after designationand before application for marketing approva
Pharmaceuticals and Medical Devices Agency	Consultation on research before applicationfor authorization

Note 1: Pharmaceuticals and Medical Devices　Agency offers consultation to support venture firms from February 1, 2009.

Note 2: A fee is required to consult with thePharmaceuticals and Medical Devices Agency.

Services to Promote Development of Medicinal Products for Rare Diseases

Guidance and Advice

Services to Promote Development of Medicinal　Products for Rare Diseases