Division of Strategic Planning and Evaluation Support Program for Orphan drug prior to the Designation


Key Fields Drug Discovery & Development(1st)
R&D phase Nonclinical Study/Pre-clinical Study, Clinical Trials, Clinical Research
Division of Strategic Planning and Evaluation, Office of Drug Discovery Support, Department of Innovative Drug Discovery and Development (iD3)
TEL: (East Japan Office) Tel : +81-3-3516-6181
(West Japan Office) Tel : +81-6-6372-1771
E-mail: id3desk”AT”amed.go.jp(※Replace “at” with @.)

Various support programs for pharmaceutical companies have been provided to accelerate the development for orphan drugs after designated by the Minister of Health, Labour and Welfare (MHLW), however not enough opportunities are currently available to promote the development prior to the designation. This issue inhibits pharmaceutical companies from proceeding with their R&D because wide range of the development such as a formulation and preclinical studies to early clinical trials are also required before they get the approval.

This program aims pharmaceutical companies (R&D style) to obtain the approval as orphan drugs and its objective is to improve the R&D environment and enable the practical application of orphan drugs promptly and effectively.

Note, however, this program does not automatically secure to be designated as an orphan drug by the Minister of Health, Labour and Welfare (MHLW).

Last updated 04/04/17