Israel's Health Ministry announced on Tuesday a comprehensive plan to overhaul its medication approval process, aiming to significantly reduce registration timelines while maintaining rigorous safety standards. The new regulatory framework, scheduled to launch in March 2025, promises to accelerate patient access to new treatments across the country.
Streamlined Approval Pathways
The reformed system introduces multiple approval tracks designed to address different medication categories and clinical needs. A key feature includes expedited registration for drugs already approved by leading regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
"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 explained.
This approach mirrors recent international trends, including New Zealand's newly approved "Rule of Two" pathway, which will allow medicines approved in two recognized jurisdictions to receive approval in less than 30 days.
Innovation and Generic Access
In a notable development, the framework establishes a new approval track for first-time generic medications that have not yet received approval in other countries. This initiative aims to expand treatment options for patients while fostering pharmaceutical innovation within Israel.
The plan also includes provisions for urgently needed medications, creating accelerated pathways for drugs required by specific patient populations. This component addresses critical treatment gaps and ensures timely access to essential therapies.
Maintaining Safety Standards
Dr. Osnat Luxenburg, Head of the Division of Medical Technologies, Information and Research at the Health Ministry, emphasized that safety remains paramount: "Israel's drug registration process adheres to international standards to ensure that every marketed medication is safe, effective, and of high quality."
The ministry's approach balances efficiency with thorough evaluation, leveraging international data while maintaining appropriate oversight of medications entering the Israeli market.
Economic and Healthcare Impact
The streamlined process is expected to make Israel a more attractive location for pharmaceutical companies seeking regulatory approvals, potentially increasing the range of available medications.
"Shortening drug registration timelines will make Israel a more attractive location for pharmaceutical approvals, thereby increasing drug availability," noted Moshe Bar Siman Tov, Director-General of the Health Ministry.
Healthcare experts anticipate that faster approval processes could particularly benefit patients with rare diseases or those requiring novel therapies, who have historically faced longer waits for treatment access.
Implementation Timeline
The new framework is scheduled to begin operation at the end of March 2025, following a period of regulatory preparation and system development. The Health Ministry has indicated that the plan represents a significant modernization of Israel's pharmaceutical approval landscape, aligning it with advanced Western regulatory standards while addressing specific national healthcare needs.
