Achievements and challenges of the Sakigake designation system in Japan-Reference-Cited by-同舟云学术

Achievements and challenges of the Sakigake designation system in Japan

Published:2021-03-22 Issue:10 Volume:87 Page:4027-4035
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Brit Jnl Clinical Pharma

Author:

Tanaka Mototsugu¹^ORCID,Idei Mayumi¹,Sakaguchi Hiroshi¹,Kato Ryosuke¹,Sato Daisuke¹,Sawanobori Kenji¹,Kawarasaki Shuichi²,Hata Toshiyuki³,Yoshizaki Asako⁴,Nakamura Miki⁵,Ikuma Mutsuhiro¹

Affiliation:

1. Office of New Drug 1 Pharmaceuticals and Medical Devices Agency Tokyo Japan

2. Office of New Drug 2 Pharmaceuticals and Medical Devices Agency Tokyo Japan

3. Office of New Drug 3 Pharmaceuticals and Medical Devices Agency Tokyo Japan

4. Office of New Drug 4 Pharmaceuticals and Medical Devices Agency Tokyo Japan

5. Office of New Drug 5 Pharmaceuticals and Medical Devices Agency Tokyo Japan

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/bcp.14807

Reference28 articles.

1. Delays in New Drug Applications in Japan and Industrial R&D Strategies

2. Significant Differences in Drug Lag in Clinical Development Among Various Strategies Used for Regulatory Submissions in Japan

3. Closing the drug lag for new drug submission and review in Japan: An industry perspective

4. Approval of new drugs 1999-2007: comparison of the US, the EU and Japan situations

5. New drug approvals in six major authorities 2010‐2019: Focus on Facilitated Regulatory Pathways and Internationalisation;Rodier C;R&D Briefing,2020

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