The
Health Ministry
announced on Tuesday a new initiative aimed at streamlining and expediting the approval process for new drugs.
The objective of the updated framework is to reduce the duration required for the registration of new items.
medications
In Israel, the ministry reports that medications will be more easily accessible to the public.
The initiative scheduled to start by late March 2025 is aligned with stringent Western regulatory guidelines. It aims to expedite treatment access for patients without compromising on safety protocols.
The Health Department is implementing a new regulation aimed at shortening wait times, which will vary according to the specific medication and the information provided.
A new approval pathway will enable first-time generics.
drugs
those that have not received approval anywhere else to be registered in Israel, thereby increasing treatment accessibility and fostering innovation.
A fast-track plan
The proposal will also feature a mechanism to expedite the approval of medications that are critically required for particular patient communities, as stated by the ministry.
Health Minister Uriel Busso pointed out that the plan “features streamlined application processes for medications already endorsed by prominent agencies like the FDA and EMA, utilizes global testing data to prevent redundant efforts, and offers regulatory leeway for uncommon conditions and urgent situations.”
Director-General of the Health Ministry Moshe Bar Siman Tov said, “Reducing the duration of drug approval processes will position Israel as a more appealing site for pharmaceutical clearances, thus enhancing medication accessibility.”
The Head of the Division of Medical Technologies, Information, and Research at the Health Ministry, Dr. Osnat Luxenburg, stated: “Israel ensures that its drug approval process aligns with global standards to guarantee all distributed medications are safe, efficacious, and of superior quality.”