New MOH guidelines to expedite approval of biosimilars and generics
Two recent MOH Guidelines which just entered into force provide for an expedited approval process of biosimilars and generic products and are intended to prioritize and significantly accelerate launch of biosimilars and generic products. The ‘Prioritized Approval Process’ Guidelines provide that if the marketing of a biosimilar/generic product is expected to generate significant cost savings, […]
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 […]
Israel Life Sciences Commercialization and Life Sciences Regulation Q&As by Liad Whatstein & Co.
Our firm recently published on the Thomson Reuters Practical Law platform two new Q&A guides for the Israeli judicial landscape regarding Life Sciences Regulation and Commercialization. The guides can be consulted on Thomson Reuters Practical Law:• Life Sciences Regulation in Israel: Overview• Life Sciences Commercialisation in Israel: Overview Or directly on our website:• Life Sciences […]