Drug registration reform in Israel: processes are being streamlined and timeframes shortened to increase supply and lower prices
We are living in an era of revolutionary medical innovation, particularly in the research and development of medicinal products. Diseases that were once considered incurable, are now treated with drugs, vaccines and cutting-edge medical technologies that stabilize patients’ conditions, improve their quality of life and, in some cases, even result in complete cures.
The challenge that many countries are facing, particularly countries with national health insurance such as Israel, is to strike a balance between the rapid adoption of new patented drugs (“ethical drugs”), which are relatively expensive but contribute enormously to patients, and encouraging the introduction of generic drugs into the market, which are significantly less expensive, as close as possible to the expiration date of the patent on the ethical drug.
The registration procedures for new drugs are a key component in balancing between medical innovation and their rapid public availability and lowering drug prices by enabling generic drugs to enter the market.
In order to register a new drug and market it to the public, a dossier containing an application and numerous documents and data, including the results of clinical trials and reports of side effects, must be submitted to the Ministry of Health, which assesses the safety, efficacy and quality of the drug. Over the years, the registration process in Israel has become very long, complex and cumbersome, and the Ministry of Health has 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 has changed its policy and published a new outline to dramatically shorten registration timeframes
The Ministry of Health published a new outline recently, which is designed to significantly shorten the registration timeframes for new drugs, ethical drugs and generic drugs. The outline is based on its adoption of a new approach of higher cooperation between the Ministry of Health and leading drug registration authorities around the world, while relying on approvals issued in other countries before applications were submitted for registration in Israel. This approach has the potential to significantly shorten the registration timeframes for drugs that fulfill the relevant criteria, to expand the availability and supply of new drugs in Israel, and to reduce medicine prices in the future.
Regulatory reliance is an accepted process, in which a regulatory authority takes other regulatory authorities’ assessments into account during its decision-making process, after it has received all of the information that was submitted to them. Reliance does not require uniform decision-making among different countries and authorities and does not diminish their independent judgment, but it does make it possible to streamline processes.
Highlights of the new outline
The new outline is based on the Ministry of Health’s recognition of a drug’s earlier registration in another country, by one of the six leading authorities that are signatories on an information sharing and cooperation agreement with the Ministry of Health – the FDA (US Food and Drug Administration), the EMA (European Medicines Agency), SWISSMEDIC (the Swiss medicines and medical devices regulatory authority), HC (Health Canada), the MHRA (the UK Medicines and Healthcare Regulatory Agency) and the TGA (the Australian Therapeutic Goods Administration).
Thus, for example, an application for the registration of a new ethical drug that was registered during the last 5 years by one of the recognized authorities 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. A similar reliance track for completing the registration process within 120 working days also applies to generic drugs.
Furthermore, if the original drug was registered by two recognized authorities, at least one of which is the FDA or the EMA, during the last 3 years before it was submitted for registration in Israel, the registration can be completed in just 70 working days.
The Ministry of Health has also proposed a new track in order to encourage the rapid entry of generic drugs into the Israeli market and to lower prices, under which companies will be offered professional guidance and ongoing advice on the registration of a new generic drug in Israel, when at issue is a first registration in the world, and if up to 3 identical generic drugs are registered in Israel or are in the process of being registered.
The outline came into immediate effect at the end of March 2025 as a regulatory pilot for new submissions of registration applications. Over the next two years, data will be collected about the outline from various parties, particularly from pharmaceutical companies and medical institutions, and further measures will be formulated for the coming years.
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Adv. Efrat Cohen is a senior partner in our firm’s regulations department.
Our firm specializes in providing professional advice and assistance in the field of Healthcare Regulation, and provides comprehensive legal services to institutions, companies and businesses operating in the medical sector, including during registration processes for medicines and medical devices, regulatory proceedings at relevant authorities, complying with complex regulatory requirements, compliance with international standards, advice on regulatory and commercial agreements and ongoing legal services to clients.