A Review of the Regulatory Framework for Initiation and Acceleration of Patient Access to Innovative Medical Products in Japan-Reference-Cited by-同舟云学术

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A Review of the Regulatory Framework for Initiation and Acceleration of Patient Access to Innovative Medical Products in Japan

Published:2019-03-18 Issue:3 Volume:106 Page:508-511
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Matsushita Shunsuke¹,Tachibana Keisuke¹,Nakai Kiyohito²,Sanada Shoji³,Kondoh Masuo¹

Affiliation:

1. Graduate School of Pharmaceutical Sciences Osaka University Osaka Japan

2. Pharmaceutical Safety and Environmental Health Bureau Ministry of Health, Labour and Welfare Tokyo Japan

3. Academic Clinical Research Center Department of Medical Innovation Osaka University Hospital Osaka Japan

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1383

Reference5 articles.

1. US Food and Drug Administration.Fast track breakthrough therapy accelerated approval priority review.

2. European Medicines Agency.Human medicines: regulatory information.

3. Ministry of Health Labour and Welfare. Strategy of SAKIGAKE.

4. Inoue S.Regulatory update from MHLW/PMDA.

5. First Approval of Regenerative Medical Products under the PMD Act in Japan

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