Clinical trials involving the use of Cannabis and its derived products in Israel

Clinical trials involving the use of Cannabis and its derived products in Israel

Cannabis Research and Development in Israel

In the past decade, the cannabis industry has become extremely dynamic and is moving forward all over the world, especially in Israel. Many countries are now approving Cannabis products to be used both for medical and recreational purposes. As a result, agricultural, manufacturing, research and business activities are being developed in these places, not only for local markets but also for export.

Many medical studies and clinical trials are being conducted on the cannabis plant, cannabis products, and substances looking for the physiological, neurological and psychological effects of its active substances on both animals and humans. This research has a preclinical and clinical trial framework. In recent years, innovative studies have been published showing a high potential for the efficacy and safety of cannabis products as a treatment for new indications.

In general, Israel is considered a global leader in cannabis, and particularly in the research and development fields. Many academic institutions, research facilities, start-up companies, pharma companies, and hospitals have begun to cooperate in this field, with the collaboration and financial support of the Ministry of Health. In Israel, there are around 40,000 patients that are treated with medical grade cannabis-based drugs (GMP certified) and with respect to population size, Israel is among the most progressive country in the field of medical cannabis, in relation to other countries around the world.

Treatment of patients with cannabis products in Israel

Cannabis products have been found effective for many diseases and illnesses. These include epilepsy, post-traumatic stress disorder, Parkinson’s disease, migraines, multiple sclerosis, Crohn’s disease, chronic pain, autism, certain cancers, and Tourette’s syndrome. Not all of them have undergone clinical trials as required by the global health authorities such as the FDA, but for those which did, the results are impressive and statistically significant.

Israeli regulations of scientific trials and clinical trials in medical cannabis

In any arrangement relating to the use of cannabis for medical purposes, Israel is bound by the strict observance of the provisions of the Dangerous Drugs Ordinance (New Version) 5733-1973 and its regulations, as well as the provisions of the Single Convention on Narcotic Drugs.

According to the Israeli government’s decision, it was determined that the Ministry of Health will maintain a ‘government agency’ in accordance with the provisions of the convention. For this purpose, the Medical Cannabis Unit (“YAKAR”) was established in 2013 and is in charge of regulating cannabis for medical use and research.

Applications for studies using cannabis are divided into two groups: clinical research or Research & Development for medical devices and pharmaceutical cannabis products (R & D).

Applications for clinical research including human trials using cannabis and its products

The Applications for a clinical trial involving the use of cannabis and its related products performed on healthy or sick people must be examined and approved in advance by the Medical Unit for Medical Cannabis of the Ministry of Health.

A request for preliminary approval should be submitted to the Clinical Trials Department and concurrently to the application a request, submitted to the Institutional Ethics Committee

The application for a clinical trial will include many details including the subject of the research, a general description of the research procedure and its contribution to the advancement of basic knowledge or medical applications (agricultural or industrial).

After the evaluation, the Committee will submit a reference for changes and amendments to be made or to approve the application in its preliminary state and the confirmation of the feasibility.

The feasibility is also required by the different medical institutions and the research proposal must be submitted to the Ethics Committee, for the issuing of Form 6 – approval of the Ethics Committee. Until receipt of Form 6, the Helsinki Committee’s approval is only a pre-confirmation.

Candidates for cannabis experiments should then prepare an expanded clinical trial application, including:

  • Confirmation of feasibility
  • Laboratory booklet – which includes the details of the safety and quality of the cannabis product to be used in the experiment: the cannabis type, the place of growth, manufacturer, plant, production procedure, GMP approval, composition of the finished product, certificate of analysis, repeatability (required in phase III trials) , concentrations, properties and properties of the product components (active substances: THC, CBD and others), as well as information on literature for intended use.
  • Consent form – which deals with confidentiality. The consent to obtain a personal license for use of cannabis and details of risks and general and unique side effects for cannabis consumption.
  • Experimental protocol – The clinical trial protocol is a document describing the research plan and includes the subjects according to the “Guidelines for Clinical Trials in Human Subjects”, 2nd edition, 2016, of the Israeli Ministry of Health.
  • Form 11 – A form that lists drugs and treatments that are not allowed in combination with cannabis, cannabis-inhibiting drugs. A statement by the physician that a participant in an experiment taking or starting to take these type of drugs simultaneously with cannabis drugs will not be included in the trial or will be disregarded in the trial.

The request will undergo a parallel approval process, both in the Israeli Ministry of Health and in the NII.

The Clinical Trials Department will examine the application from the aspects of compliance with regulatory and ethical requirements.

The YAKAR (Medical Cannabis Unit of the Israeli Ministry of Health) will examine the application from the following aspects: the cannabis supplier, the cannabis product, the dose, operational procedures, licensing procedures, guidelines for cannabis production, cannabis use, and more.

The NII will forward comments on changes and amendments, or approve the application on Form 8, which is a condition for approval by the Ministry of Health for clinical research, in front of the Ethics Committee.

The medical institute will issue an approval for the clinical trial of the Principal Investigator and the Experimental Investigator, called Form 7, detailing the terms and conditions applicable to the trial.

In the final stage, before the clinical trial can be started, the investigator must submit a request form for the approval of the use of cannabis from each participant in the study. Even if he or she has a cannabis permit, the form will be submitted to a researcher who will give the final license: The participants’ licenses.

The medical cannabis will be provided to the participant by the supplier or by the investigator according to the trial protocol and the guidelines in accordance with the approval of the YAKAR. It is clarified to the participants by the researcher and is the researcher’s responsibility that they must comply with the terms of the cannabis license.

Research and development for medical cannabis devices or agricultural R & D.

Submitting a request for agricultural research and development or medical devices that use cannabis is similar to the application for clinical trials, up to the stage of confirmation of the feasibility and the preliminary approval.

For medical equipment, the application must detail the information on the materials from which the medical device is built. A description must be given of hardware and software components, operating instructions, installation and maintenance, risk Assessment experiments and trials portfolio as well as engineering tests.

For agriculture cannabis research the extended submission needs to include details about the researchers, research protocol, procedures for securing growing areas, the extent of growth, procedures for the transfer of plant material and procedures for the destruction of plant material.

The application process can seem complicated and the different offices and institutes are sometimes difficult to navigate. but based on our extended experience and dedication to the medical field we would be more than happy to help you prepare and submit your application for a clinical trial or any experiment in the cannabis field in Israel.

References:

  • Guidelines for submitting applications for cannabis research, Israeli Ministry of Health – July 2015 – The procedure for clinical trials in humans, Procedure No. 14 of the Pharmaceutical Department 2016, 2nd edition
  • Procedures of the Helsinki Institutional Committee (various medical centers such as Meir, Tel Hashomer, etc.)

About Cannabis GxP consultancy

Cannabis GXP is proud to stand at the forefront of the Cannabis industry in Israel and worldwide thanks to many years of experience in these areas.

Our team is compelled to spread the message of the importance of cannabis science, regulation and standardization as the world enters a new era of cannabis legislation.

We aim to position our clients with their best foot forward when it comes to anything and everything cannabis related.

Our vast expertise allows us to assist companies in a wide range of services and needs: Anything from Cannabis R&D, growing and manufacturing, new products development, facility design, technology, quality assurance, good practices (GAP/GMP/GLP/GDP/GCP), staff training, local and global regulations.

Cannabis GxP is a subsidiary company of Bio-Chem Ltd. (2007), a consultancy firm for the pharmaceutical field, medical devices, cosmetics, and food supplements industry based in Israel.

Our cannabis consultancy services include:

  • Product development, delivery system & clinical trials
  • Growing, Manufacturing and Lab Facilities Design
  • Quality Assurance and Good Practices (GxP)
  • Cultivation & Product Manufacturing Technology
  • New product Regulations and Submissions
  • Qualification & Validation
  • Risk Assessment
  • Staff training

If you need one or several of our services, we will be more than happy to assist.

Please do not hesitate to contact us for further information.

 

2019-06-02T14:36:41+00:00

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