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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.

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作者单位: Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel. [1] Oncology Department, Sheba Medical Center, Tel Hashomer, Israel. [2] Faculty of Medicine, Tel Aviv University Sackler, Tel Aviv, Israel. [3] Clinical Pharmacology and Toxicology Unit, Shamir Medical Center, Tzrifin, Israel. [4] The Pharmaceutical Division, State of Israel Ministry of Health, Jerusalem, Israel. [5] The Adelson School of Medicine, Ariel University, Ariel, Israel. [6] Department of Internal Medicine T, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel. [7] Department of Internal Medicine E, Sheba Medical Center, Tel Hashomer, Israel. [8] Nephrology Department, Hillel Yaffe Medical Center, Hadera, Israel. [9] The Ruth and Bruce Rappaport Faculty of Medicine, Technion Israel Institute of Technology, Haifa, Israel. [10] Oncology Institute, Carmel Medical Center, Haifa, Israel. [11] Oncology Department, Shamir Medical Center, Tzrifin, Israel. [12] Hematology Department, Shaare Zedek Medical Center, Jerusalem, Israel. [13] Department of Hematology, Hadassah Medical Center, Jerusalem, Israel. [14] Clinical Pharmacology Unit, Kaplan Medical Center, Rehovot, Israel. [15] Hadassah University Medical Center Sharett Institute of Oncology, Jerusalem, Israel. [16] Department of Internal Medicine, Shaare Zedek Medical Center, Jerusalem, Israel. [17] Medical Technology, Health Information and Research Director, State of Israel Ministry of Health, Jerusalem, Israel. [18] The Pharmaceutical Division, State of Israel Ministry of Health, Jerusalem, Israel denizekib@gmail.com. [19]
DOI 10.1136/bmjopen-2022-067313
PMID 37142315
发布时间 2023-05-12
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