The process of pharmaceutical and drug product registration in Israel
The main regulatory body for pharmaceutical administration in Israel is the Registration Department of the Ministry of Health of the State of Israel (IMOH). The department activities are based on the Pharmacy Regulations of 1986. The regulations are periodically updated.
According to the pharmacy regulations, a medicinal product must be registered in the National Drugs Registry after its quality, safety and efficacy have been proven. The IMOH registration department is responsible for the content of the drug product registry and for updating it.
The main goal of registration is, obviously, to protect public health and it acts as a barrier to the marketing of poor quality and dangerous/unsafe/adulterated medicines. It also enables physicians to prescribe, with a high degree of confidence, safe and effective medicines to patients.
The IMOH registration department sets policies and procedures for the registration of medicinal preparations containing new substances (innovative products) as well as generic medicines, makes rules regarding limitations to marketing of medicines, and provides information to the public, patients and physicians by publishing leaflets, labels, policies on approval of medicine advertising and promotional materials, and more.