Israel’s Drug Registration Reform

The Israeli Ministry of Health has launched new, quicker and more efficient registration tracks which opens new potential opportunities for U.S. businesses.

Recognizing the importance of rapid access to innovative pharmaceutical technologies, the Israeli Ministry of Health has announced a reform to improve and streamline its drug registration processes, effective March 23, 2025. The ministry emphasized that the registration of safe, effective, and high-quality medications plays a vital role in safeguarding public health. A new framework has been developed, drawing on regulatory advancements in leading Western countries. This model emphasizes collaboration, information sharing, and partial reliance on evaluations conducted by prominent international regulatory authorities. By adopting this approach, Israel aims to shorten registration timelines and deliver a broader range of treatments to patients more efficiently, ultimately improving access to cutting-edge medical care.

As part of the reform, three reliance-based registration tracks (i.e. depending on existing foreign approvals) have been introduced:

Reliance Track A – 70-day registration process for original and biosimilar products:
Designated for original products (new molecule, new strength, administration method, dosage method, or a new combination of registered active ingredients) and biosimilar products. The evaluation period is 70 working days from the receipt of the request until a registration certificate or a rejection letter is issued.

Track A applies to products registered within the past three years by at least two of the recognized regulatory authorities (FDA, EMA, MHRA, HC, SMC, TGA).

Reliance Track B – 120-day registration process for original and biosimilar products:
Also designated for original and biosimilar products, as defined above. The evaluation period is 120 working days from the receipt of the request until a registration certificate or a rejection letter is issued.

Track B applies to products registered within the past five years by one of the recognized regulatory authorities.

Reliance Track C – 120-day registration process for generic medicines:
Designated for generic products based on innovative medicines already registered in Israel. Track C applies to products registered within the past three years by one of the recognized regulatory authorities.

For the full terms and information, please visit the Israeli Ministry of Health guidelines (available in Hebrew only).

The reform and its newly adopted registration processes are expected to ease some of the regulatory burdens previously faced by U.S. companies when importing into Israel, while also presenting new opportunities in the local healthcare and pharmaceutical market.

For additional information on opportunities in the healthcare sector in Israel, please contact Commercial Specialist Inbar Marom at inbar.marom@trade.gov.