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 […]
IL Biosimilar Update: New MOH Guidelines Facilitate Registration of Biosimilars
The updated Biosimilar Registration Guidelines of the Israeli Ministry of Health (“Procedure 127”) will enter into force on July 15th, 2023. The updated Guidelines are intended to facilitate registration of biosimilar products and the switching to biosimilar products from the reference product. According to the updated Guidelines, a biosimilar product submitted for approval in Israel […]