An impact analysis of the implementation of health technology assessment for new treatment of orphan diseases in Japan

Author:

Kogushi Kentaro12,Ogawa Toshio3,Ikeda Shunya1

Affiliation:

1. Graduate School of Medicine, International University of Health and Welfare, Tokyo, Japan

2. Medical Affairs, Otsuka Pharmaceutical Co., Ltd., Tokyo, Japan

3. Graduate School of Health and Welfare Sciences, International University of Health and Welfare, Tokyo, Japan

Funder

funded

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Health Policy,General Medicine

Reference31 articles.

1. Orphan drugs: the regulatory environment

2. Access to Orphan Drugs: A Comprehensive Review of Legislations, Regulations and Policies in 35 Countries

3. Minister of Health, Labour and Welfare. Tokyo. Overview of Orphan Drug/Medical Device Designation System. [cited 2019 Jul 26]. Available from: https://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/orphan_drug.html

4. Health Canada Office of Legislative and Regulatory Modernization, Initial Draft Discussion Document for a Canadian Orphan Drug Regulatory Framework, 2012 Dec 13. Available from: https://www.raredisorders.ca/content/uploads/Proposal-for-Orphan-Drug-Framework_dec-12-2012.pdf

5. Common drug review recommendations for orphan drugs in Canada: basis of recommendations and comparison with similar reviews in Quebec, Australia, Scotland and New Zealand

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