Around the world cannabis is designated as a Schedule 1 substance which impedes the implementation of human clinical trials approved by health regulators in the US and most western countries. The chemistry of a drug under development must be known and reproducible in terms of creating a standardized dose. In the US, the DEA requires that the investigation of marijuana for medical use in a manner acceptable as support for marketing approval under a new drug application, clinical studies under an investigative new drug of consistent batches of a particular marijuana product for particular disease indications should be conducted.
Israel’s highly accommodating regulatory environment combined with its world renown medical research ecosystem provides a perfect opportunity for conducting FDA and EMA compliant clinical trials on humans. Launching clinical studies in Israel is the quickest and least costly path to developing and commercializing phytocannabinoid drugs. Israel offers a wealth of knowledge and human resources, including scientists, entrepreneurs, academic institutions and industry partners, to drive phytocannabinoid clinical research. These include leading FDA and EMA approved hospitals and medical centers, world renown medical professionals, a multitude of preclinical and clinical trial support organizations, production of the full range of cannabinoid based pharmaceutical ingredients from plants grown under strict GAP criteria.