ISRAEL Law and Practice Contributed by: Lior Glassman, Matan Kovacs, Alexandra Cohen and Tamar Morag Sela, Reinhold Cohn Group
Medicines In February 2024, the MoH published a tem- porary framework for the approval of generic or biosimilar drug imports under Regulation 29 of the Pharmacists Regulations (Preparations) of 1986. This framework introduces expedited regulatory pathways by allowing conditional import approval for up to ten pharmaceuticals that meet the predefined criteria. The approval process requires, inter alia, that: • the pharmaceutical must be generic or bio- similar; • the pharmaceutical must be registered in rec- ognised regulatory markets (such as the USA, the EU and the UK); • the original pharmaceutical must be already registered in Israel; and • there must be two or fewer registered phar- maceuticals for the same active ingredient in Israel. Applications to import such drugs can only be submitted by HMOs, with a permit being granted automatically after 45 working days, unless the MoH decides otherwise. Once issued, the per- mit is valid for up to one year, and extendable based on compliance with registration require- ments. The framework aims to facilitate patient access to essential medications while ensuring regulatory oversight and cost-effectiveness, with the savings being used to improve healthcare in Israel. Medical Devices In 2024, the MoH published two guidelines for fast track registration of medical devices, intro- ducing simplified procedures for Class I and Class II devices. The first guideline, published in January 2024, established an expedited route for low-risk devices (Class I and IVD Class A),
device in question, and others. Renewals may also require the filing of information regarding ongoing obligations. The Medical Device Law of 2012 also authorises the Minister of Health to establish quality control regulations. However, these regulations have not yet been issued. 3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices Pending applications for marketing authorisa- tions for pharmaceuticals and medical devices remain confidential until registration. Basic infor- mation only (such as name, active ingredients, indications, dosage forms, and other details) becomes accessible to third parties upon com- pletion of the registration process. The Israeli Drug Registry is available on the MoH’s website, which also features additional information such as information on preparations that are no longer marketed in Israel and notices regarding certain defects and side effects. The MoH may use data to authorise generics only after the market exclusivity period ends. Medical Devices Registered Israeli medical devices are public and available on the MoH’s website. At this stage, the information available online is not complete. 4. Regulatory Reliance and Fast Track Registration Routes 4.1 Fast Track Registration Routes Israel’s regulatory framework offers fast track registration routes both for medicines and medi- cal devices, as detailed here.
177 CHAMBERS.COM
Powered by FlippingBook