"העלון לרופא" לתרופות: היבטים משפטיים ורגולטוריים

The regulation of pharmaceuticals is becoming more complex in recent years. Current regulation is no longer limited to deciding whether a specific drug would be allowed to be placed on the market. Today, a significant part of the regulatory process is focused on setting the terms for utilization of each drug, regarding the target population, dosages, mode of administration, etc. These terms have enormous implications on both pharmaceutical companies and caregivers. In Israel, the only publicly available source of information on terms of registration is the prescribing information ("physician leaflet"). The prescribing information contains instructions for use, as well as a Lot of safety information regarding the product. Therefore, the wording of the prescribing information may have serious regulatory and legal implications on caregivers. The objective of this article is to describe the relevant laws and regulations requiring its publication, while discussing the practical issues and implications of the use of prescribing information by physicians in Israel.