REGISTRATION IN ISRAEL: GUIDELINES

The Pharmaceutical Section of the Manufacturers' Association of Israel, which represents over 201 drug companies, has sponsored the publication in English of the Guidelines for Filing Applications for Registration of Medicinal Products in Israel.

The publication provides information on the dossier to be submitted in support of a registration application, and also for renewals and amendments. Full instructions are provided on: the documentation which is required from the country of origin; data on the method of manufacture and quality control of the active ingredients and of the finished form; stability data; pharmacotechnical data by type of dosage form; prescribing information for the physician; the patient package insert; packaging; and labeling. The scope of the preclinical and clinical data required is also detailed.

A series of annexes sets out guidelines for bioavailability testing, requirements for registration of various types of generic products, model texts for the patient package insert (these are now required to be printed in three languages - Hebrew, Arabic and English), and the exact content of the various application forms.