• April 10, 2024

IL Ministry of Health Update: New “VIP Super Fast-Track Registration” for generic/biosimilar drugs

The IL Ministry of Health launched a new “VIP Super Fast-Track Registration” which will allow for marketing of imported generic and biosimilar drugs within 45 days from the date of filing the fast-track application. The new fast-track option is open for up to 10 products per year which will be selected by the HMOs (Sick Funds).

Products which have been registered in the last three years in the EU (Centralized, Decentralized or MRP), FDA, Switzerland (SMC), Canada (HC), Australia (TGA) or England (MHRA) and are marketed in any of these jurisdictions are eligible for the fast-track process, provided they do not possess an exceptional adverse events profile; their safety profile is similar to the product registered in Israel; marketing approvals for the product were not withdrawn or rejected; and imports to Israel are from manufacturing batches marketed in a country where the product was registered. The IL MOH will have 45 days to review whether the products satisfy these conditions, and, in such case, the IL Ministry of Health will provisionally rely on approvals by foreign regulatory authorities until an independent review of the regulatory file by the IL MOH is completed.

The new guidelines will be in force in 2024-2025 and will then be re-evaluated. They have been fiercely criticized by both the innovative industry and the local generic industry. They divert the limited MOH resources from innovative to generic/biosimilar products, prioritize imported over locally manufactured products which still require complete regulatory review and renders the MOH regulatory review de facto meaningless. Although parties invoking the new fast-track regulatory process are required to declare that the marketing of the drug in question is permitted under the Patents Act, we expect the new pathway will also encourage launch-at-risk of patent infringing drugs.

This update article is provided for general information only and is not in lieu of legal advice. Please contact us directly for any required advice on specific matters.

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