Israel

Israel is regulated by the Ministry of Health (MoH) — Pharmaceutical Administration (Minhal HaRokchut, often abbreviated 'IMA' for Israeli Medicines Agency) headquartered in Jerusalem. The framework is set by the Pharmacists Ordinance (New Version) 5741-1981 and the Pharmacists Regulations (Preparations) 5746-1986, with detailed MoH Procedures (Nohalim) governing registration, variations, GMP, clinical trials and pharmacovigilance. Israel is a PIC/S full member (since 2009) and a recognised reference regulator under several reliance frameworks abroad. Effective 23 March 2025, the MoH launched a major Drug Registration Reform that consolidates and expands the historical 'recognised regulators' route into formal accelerated reliance tracks. Israel relies on assessments from a defined list of recognised regulatory authorities (US FDA, EMA, MHRA, Swissmedic, Health Canada, TGA, PMDA) for both new chemical entities and biologics. Submissions to the Pharmaceutical Administration are in Hebrew or English; the MoH operates the Israeli Drug Registry (israeldrugs.health.gov.il). Reimbursement is governed by the National Health Insurance Law 5754-1994 through the annual 'Sal HaBriut' (Health Basket) update — a structured HTA-style process led by the MoH Drug Basket Committee (Va'adat Sal HaTrufot) that ranks new technologies under a fixed annual budget allocated by the government. The four health funds (Clalit, Maccabi, Meuhedet, Leumit) deliver the basket on a capitated basis.