Process of drug registration in Israel: the correlation between the number of discussions within the Ministry of Health and postapproval variations by EMA and/or FDA

Process of drug registration in Israel: the correlation between the number of discussions within the Ministry of Health and postapproval variations by EMA and/or FDA

Objectives US FDA and EMA allow facilitated regulatory pathways to expedite access to new treatments. Limited supportive data may result in major postapproval variations. In Israel, partly relying on Food and Drug Administration (FDA) and European Medicines Agency (EMA), clinical data are reviewed i...

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Bibliographic Details
Main Authors: Katerina Shulman, Ilana Weiss, Matitiahu Berkovitch, Shai Ashkenazi, Moshe E Gatt, Osnat Luxenburg, Stephany Hiayev, Einat Shacham-Shmueli, Michal Hirsch Vexberg, Rami Hershkowitz, Einat Gorelik, Haim Mayan, Yehudit Steinmetz, Noa Berar Yanai, Orly Schlissel, Muhammad Azem, Neriya Gutgold, Milly Divinsky, Nirit Yarom, Alla Vishkautzan, Chezi Ganzel, Lidia Arcavi, Eli Marom, Biatrice Uziely, Shoshana Zevin, Hadar Meirow, Denize Ainbinder
Format: Article
Language:English
Published: BMJ Publishing Group 2023-05-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/13/5/e067313.full

Internet

https://bmjopen.bmj.com/content/13/5/e067313.full

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