Pharmaceutical and Drug Product Registration and Submissions in Israel

The Process of Pharmaceutical and Drug Product Registration in Israel

The Bottom Line for Pharmaceutical Manufacturers and Marketing Authorization Holders:
The Israeli pharmaceutical market is undergoing a significant regulatory transformation through the 2025-2026 Registration Reform. This reform introduces accelerated reliance tracks that can reduce registration timelines to as little as 70 days for products already approved by the FDA or EMA. To capitalize on these efficiencies manufacturers must appoint a professional Israeli Registration Holder (IRH) and a Qualified Person (QP) pharmacist to manage the submission and long-term pharmacovigilance. Navigating these new tracks requires precise technical file preparation and a deep understanding of the updated Pharmacy Regulations to ensure safe and timely market entry.

The main regulatory body for pharmaceutical administration in Israel is the Registration Department of the Ministry of Health of the State of Israel (IMOH). The department activities are based on the Pharmacy Regulations of 1986. These regulations are periodically updated to align with Western standards. According to the pharmacy regulations a medicinal product must be registered in the National Drugs Registry after its quality, safety, and efficacy have been proven. The IMOH registration department is responsible for the content of the drug product registry and for updating it.

The main goal of registration is to protect public health and it acts as a barrier to the marketing of poor quality and dangerous or adulterated medicines. It also enables physicians to prescribe with a high degree of confidence safe and effective medicines to patients. The IMOH registration department sets policies and procedures for the registration of medicinal preparations containing new substances—innovative products—as well as generic medicines. It also makes rules regarding limitations to the marketing of medicines and provides information to the public and physicians through leaflets, labels, and policies on the approval of medicine advertising.

Pharmaceutical Drug Product Registration Requirements in Israel

Before and during the IMOH product registration process you need to ensure the quality, safety, and efficacy of the medicinal product.

The Israeli registration holder must adhere to strict regulatory requirements including the following items:

Every pharmaceutical product must have a comprehensive registration file.
The registration holder via an authorized licensed pharmacist may register a pharmaceutical product in Israel.
The registration holder must be an official Israeli representative of the drug product manufacturer or rights owner.
Appointing a QP pharmacist or local consulting firm who will be responsible for all medicine registration activities and interactions with the IMOH.
Submission of a registration file and sample analyses if necessary for marketing a new medicine.
Reporting and monitoring of possible variations in the registration conditions of the medicine.
Updating information about the registration condition when required and remaining aware of regulatory changes.
Obtaining an annual import license or approval if the medicine is manufactured outside of Israel.

The 2025-2026 Drug Registration Reform Tracks

Effective from March 2025 the IMOH has introduced a reliance-based reform to accelerate timelines for drugs approved by leading authorities such as the FDA, EMA, or MHRA. These new pathways significantly reduce the previous 180-day to 270-day review cycles:

Registration Track	Timeline (Business Days)	Eligibility Criteria
Reliance Track A	70 Days	Original and biosimilar products registered in the past 3 years by at least two recognized authorities.
Reliance Track B	120 Days	Original and biosimilar products registered in the past 5 years by at least one recognized authority.
Reliance Track C	120 Days	Generic medicines based on innovative products already registered in Israel and one recognized authority.

The Pharmaceutical Medicinal Drug Product Registration Process in Israel

The registration process follows a structured sequence of technical reviews and committee discussions.

1. Application Submission

Completion of application forms and submission of relevant dossiers—Dossier A for administrative data and Dossier B for technical data—based on the specific pharmaceutical product type.

2. Technical and Quality Review

The documents are reviewed by the IMOH registration department. Simultaneously the Institute of Control and Certification of Pharmaceutical Materials reviews the documentation to issue a quality certification for the product.

3. Committee Discussion

The application is forwarded to the Advisory Committee for Drug Registration (ACDR) for professional discussion and recommendation.

4. Final Registration

After quality certification approval the process continues at the registration department. If no deficiencies are found the drug product is officially registered in the National Drugs Registry. Registration is typically valid for 5 years.

The Vital Role of the Responsible Pharmacist (QP)

In Israel the Responsible Pharmacist (QP) is the gatekeeper of quality. This professional is personally liable for the batch release of pharmaceuticals to the market. They must ensure that every batch—whether locally manufactured or imported—complies with the registration dossier and marketing authorization license terms. Partnering with a professional firm ensures that your pharmacovigilance and risk management plans meet the specific adaptations required by the Israeli Pharmaceutical Division.

Frequently Asked Questions

What are the recognized reference countries for the new 2026 reliance tracks?
The IMOH recognizes major authorities including the FDA (USA), EMA (Europe), MHRA (UK), Health Canada, TGA (Australia), and Swissmedic. Approvals from these bodies can lead to the 70-day or 120-day accelerated registration pathways.

Does a generic drug require the same clinical data as an innovative drug?
No. For generic registrations under Track C the applicant typically provides bioequivalence data to prove the drug is identical in strength and active substance to the innovative drug already registered in Israel.

Is a local QP pharmacist mandatory for foreign manufacturers?
Yes. Israeli law requires every pharmaceutical importer or manufacturer to appoint a local Responsible Pharmacist (QP) who is licensed in Israel and has the authority to release batches to the market.