New Measures Can Cut Israel’s Drug Approval Time To Just 70 Days

Israel’s drug regulator has introduced new measures to substantially cut the time it takes to register drugs in the country, for example, by shortening the time from 180 working days to just 70 days in certain cases.

The measures, introduced under a new pilot project, involve a two-pronged approach that the Ministry of Health believes will expedite the availability of innovative medicines in Israel, lower operational costs, and consequently reduce prices, while ensuring compliance with safety and quality standards.

One approach will involve Israel’s Pharmaceutics Division of the Ministry of Health relying on the drug registration decisions already issued by leading regulators around the world including those in the US and the EU.

The other involves the implementation of a new pathway for the first-time registration in Israel of generic drugs that are not registered elsewhere globally.

The pilot project kicked off on 23 March for all drugs submitted for registration to Israel’s drug regulator. It will run through 2025 and 2026. “Following data collection and evaluation of the framework’s outcomes, additional measures will be formulated for 2027,” the Ministry of Health said.

Commenting on the need for the new framework, Israeli law firm Barnea Jaffa Lande said that the registration process in Israel had become “very long, complex and cumbersome” over the years and that the Ministry of Health had “often deviated from the statutory deadlines for completing the process. As a result, drugs marketed abroad were not available to patients in Israel or were allowed in the local market much later than in other countries.”

The Ministry of Health’s director general, Moshe Bar Siman Tov, said that “by shortening drug registration timelines, we aim to increase drug availability in Israel, making the country a more attractive destination for drug registration. This is a vital step that will expand the supply of medications to patients and help reduce prices through market competition.”

Using International Reliance To Speed Registrations

Under the international regulatory reliance procedure, Israel’s drug regulator will recognize a drug’s previous registration in another country based on assessments made by one of the six regulatory authorities that are signatories to an information sharing and cooperation agreement with the Ministry of Health, according to Efrat Cohen, a senior partner at Barnea.

Doing so is expected to speed up registrations in Israel and minimize unnecessary duplication of work by the country’s regulator.

The six authorities are the US Food and Drug Administration, the European Medicines Agency, Switzerland’s Swissmedic, Health Canada, the UK Medicines and Healthcare products Regulatory Agency and Australia’s Therapeutic Goods Administration.

For original drugs – ie patented products based on newly developed molecules – the Pharmaceutics Division can use the international reliance pathway to register a product within 70 or 120 working days upon submission of the required information. Previously, these drugs were approved within a timeline of up to 180 working days.

Cohen explained that if the drug was registered by one of the recognized authorities during the last five years it will be approved within 120 working days. “The precondition to this is that the application dossier being submitted in Israel must be identical to the dossier approved by the authority on which the ministry wants to rely, including identical indication and dosage regimen.”

If the original drug was given the thumbs up for registration by two recognized authorities, at least one of which is the US FDA or the EMA, during the last three years before it was submitted for registration in Israel, “the registration can be completed in just 70 working days,” Cohen said.

The Barnea lawyer noted that “a similar reliance track for completing the registration process within 120 working days also applies to generic drugs.”

For biosimilar drugs, the ministry said that the registration timeline for these products, previously set at 270 days, would also be reduced to a maximum of 70 or 120 days under the new framework.

The ministry noted that while it can take into account, and give some weight to, assessments made by other regulatory authorities when using the reliance mechanism, it will maintain its independence when making a decision.

Encouraging Rapid Entry Of Generics

Regarding the new pathway for the first-time registration in Israel of generic drugs that are not registered elsewhere, Cohen said that this track was designed to “encourage the rapid entry of generic drugs into the Israeli market and to lower prices.”

Companies using the pathway “will be offered professional guidance and ongoing advice on the registration,” she explained.

A Significant Advancement

Israel’s minister of health, Uriel Buso, said the new drug registration mechanisms represented “a significant advancement” in the ministry’s “ongoing commitment to streamline regulations and expedite processes, while steadfastly safeguarding public health.”

He said that leveraging international testing data would minimize unnecessary duplication and provide “special flexibility for drugs targeting rare diseases or for compassionate use in urgent circumstances. Moreover, digital tools will be implemented to enhance transparency and optimize the submission and monitoring process.”

More details about the pilot are available in a document from the Ministry of Health that is in Hebrew.