Regulation of Clinical Trials in Israel: Recent Developments

Abstract

The aim of this article is to provide a concise overview of the new guidelines for 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 (1), 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— 1980 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 attract 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 welfare of human subjects.