A Comparative Review of Marketing Authorization Decisions in Switzerland, the EU, and the USA-Reference-Cited by-同舟云学术

A Comparative Review of Marketing Authorization Decisions in Switzerland, the EU, and the USA

Published:2019-01 Issue:1 Volume:53 Page:86-94
ISSN:2168-4790
Container-title:Therapeutic Innovation & Regulatory Science
language:en
Short-container-title:Ther Innov Regul Sci

Author:

Dalla Torre Di Sanguinetto Simon^ORCID,Heinonen Esa,Antonov Janine,Bolte Claus

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/10.1177/2168479018764660.pdf

Reference13 articles.

1. Swissmedic, Agreements on information exchange. Swissmedic Website. Swissmedic. https://www.swissmedic.ch/swissmedic/en/home/about-us/collaboration/international-collaboration/bilateral-collaboration-with-partner-authorities/agreements-on-information-exchange.html. Published 2015. Accessed March 23, 2018.

2. European Medicines Agency. European public assessment reports. European Medicines Agency Website. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d124. Accessed January 5, 2015.

3. European Medicines Agency. Withdrawn applications. European Medicines Agency Website. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d125. Accessed March 23, 2018.

4. Heads of Medicines Agencies. Human medicines: MRI product index. Heads of Medicines Agencies Website. http://mri.medagencies.org/Human/. Published 2015. Accessed Janauary 5, 2015.

5. European Commission. Community Register of medicinal products: procedures for nationally authorised medicinal products. European Commission Website. http://ec.europa.eu/health/documents/community-register/html/index_en.htm. Accessed February 17, 2016.

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