Health Ministry announces plan to simplify, speed up medicine approval process

The new framework aims to shorten the time on register new medications in Israel, making drugs more readily available to the public - without compromising safety or quality.

 Illustrative photo shows various medicine pills in their original packaging  (photo credit: REUTERS/YVES HERMAN)
Illustrative photo shows various medicine pills in their original packaging
(photo credit: REUTERS/YVES HERMAN)

The Health Ministry announced on Tuesday a new plan to simplify and speed up the process for approving new medications.

The new framework aims to shorten the time of registering new medications in Israel, making drugs more readily available to the public, according to the ministry. 

The plan, which is set to begin at the end of March 2025, is based on advanced Western regulatory standards and will help bring treatments to patients faster while maintaining high safety standards.

The Health Ministry is introducing new approval that will reduce the waiting time based on the type of drug and the data that has been submitted.

 Pills spilling out of a bottle (illustrative). (credit: INGIMAGE)
Pills spilling out of a bottle (illustrative). (credit: INGIMAGE)

A new approval track will allow first-time generic drugs that have never been approved elsewhere to be registered in Israel, expanding access to treatments and encouraging innovations.

A fast-track plan

The plan will also include a way to fast-track drugs that are urgently needed for specific patient groups, according to the ministry.

The plan "introduces expedited registration tracks for drugs already approved by leading authorities such as the FDA and EMA, relies on international test data to avoid unnecessary duplication, and provides regulatory flexibility for rare diseases and emergency use cases," Health Minister Uriel Busso noted.

"Shortening drug registration timelines will make Israel a more attractive location for pharmaceutical approvals, thereby increasing drug availability," Director-General of the Health Ministry Moshe Bar Siman Tov stated.

Head of the Division of Medical Technologies, Information and Research at the Health Ministry, Dr. Osnat Luxenburg, said: "Israel’s drug registration process adheres to international standards to ensure that every marketed medication is safe, effective, and of high quality."