The Current Status of Sakigake Designation in Japan, PRIME in the European Union, and Breakthrough Therapy Designation in the United States-Reference-Cited by-同舟云学术

The Current Status of Sakigake Designation in Japan, PRIME in the European Union, and Breakthrough Therapy Designation in the United States

Published:2017-01 Issue:1 Volume:51 Page:51-54
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Kondo Hideyuki,Hata Toshiyuki,Ito Konomi,Koike Hisashi,Kono Noriatsu

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

Link

http://link.springer.com/content/pdf/10.1177/2168479016662682.pdf

Reference14 articles.

1. US Food and Drug Administration. Regulatory information. Frequently asked questions: Breakthrough Therapies. http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDASIA/ucm341027.htm. Accessed June 13, 2016.

2. Japan Ministry of Health, Labour and Welfare. Sakigake Designation [in Japanese]. http://www.mhlw.go.jp/seisakunitsuite/bunya/kenkou_iryou/iyakuhin/topics/tp150514-01.html. Accessed June 13, 2016.

3. European Medicines Agency. PRIME: Priority Medicines. http://www.ema.europa.eu/ema/index.jsp%3Fcurl%3Dpages/regulation/general/general_content_000660.jsp%26mid%3DWC0b01ac058096f643. Accessed June 13, 2016.

4. European Medicines Agency. European Medicines Agency guidance for applicants seeking access to PRIME scheme. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2016/03/WC500202630.pdf. Published March 7, 2016. Accessed June 13, 2016.

5. European Medicines Agency. PRIME eligibility requests. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2016/03/WC500202638.pdf. Published March 7, 2016. Accessed June 13, 2016.

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