Regulation of Clinical Trials in Israel: Recent Developments
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REGULATION OF CLINICAL TRIALS IN ISRAEL: RECENT DEVELOPMENTS R A N FRENKEL,
RPH
Regional Director, ICON Clinical Research, Rehovot. Israel
MINAAEUNOS, PHD National officer. Clinical Trials Unit
HANNABILLIG,MSc National Officer. Clinical Trials Unit
ESTHERKATZ, MSc National Officer, Medical Device Unit Pharmaceutical Division, Ministry of Health, Jerusalem, Israel
The aim of this article is to provide a concise overview of the new guidelines f o r clinical studies conducted in Israel. The Guidelines for Clinical Trials in Human Subjects, prepared and published by the Pharmaceutical Division of the Ministry of Health in September 1999 (I), designate the end of an era of generalized regulatory procedures in a country increasingly chosen for clinical studies. These guidelines encompass the entire regulatory process: submission, approval, and control. All phases of clinical studies conducted in Israel, including planning, approval, conducting, documentation, and reporting. must be conducted in accordance with the following regulations and guidelines: Public Health Regulations (Medical Experiments Involving Human Subjects-1 980 including amendments and addenda until 1999): The new guidelines: The International Conference for Harmonization (ICH) Good Clinical Practice (GCP) (E6) harmonized Tripartite Guideline for Good Clinical Practice and EN 540 Clinical Investigation of Medical Devices for Human Subjects. The new standard, the continuous GCP training, and the liaison with the United States Food and Drug Administration (FDA) create a familiar regulatory environment and attruct more pharmaceutical companies to conduct their trials in Israel. The aim of these guidelines is to harmonize local regulations with ICH GCP and protect the rights, safety, and werfare of human subjects. Key Words: Clinical trials; Israel; Institutional review board; GCP; Regulations
INTRODUCTION THE LARGE VOLUME of clinical trials conducted in Israel demanded thorough regulatory action to protect human rights and safety, maintain consistency with the Decla-
Reprint address: Ran Frenkel. ICON Clinical Research Israel, 1 Hamada St.. Rehovot 76703 Israel. E-mail: [email protected].
ration of Helsinki, and establish Israel's position in the clinical research arena. With the increasing amount of clinical work the number of international contract research organizations (CROs) increased as well and the local industry, including the regulatory bodies, was exposed to international requirements and standardization' The Pharmaceutical Division of the Ministry of Health (MOH) issued the new guide-
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R. Frenkel, M.Arinos, H.Billig, and E. Katz
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FIGURE 1. The old procedure for approval a. a cllnlcal trial In a hoapltaL 7h.National Committea for C l i n h l Trials (NCCT) moob ~y 6 to 8 nmkr and is comprlsd ot: 8 physlckns with various m o d h i
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