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
National Institute of Biomedical Innovation
Consultation on research after designationand before
|Pharmaceuticals and Medical Devices Agency||
Consultation on research before applicationfor
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.