Updates by the Ministry of Health on a New Clinical Trial Process in Israel

The Life Science Industry Promotion Program

Compared to the rest of the world, the Israeli life science industry comprises a unique mix of companies (many young and small companies, high percentage of companies engaged in developing medical devices) with a large growth potential.
In order to promote this field in Israel and to attract international companies the Ministries of Health and Finance established steering committees which reviewed all the regulatory processes involved in the approval of clinical trials, examined the features of similar processes abroad, identified obstacles and details that can be used to enhance the process and also formulated a plan of action. Finally, in 2013 a program intended to promote the Life Science industry in Israel was launched.

Since the beginning of the program we managed to:
· Significant shortened the timelines for approval of clinical studies – to an average of approx. 60 days - for studies in pharmaceuticals and medical devices. This was done by enabling clinical trial applications to be submitted simultaneously to both hospitals and the Ministry of Health (at present, applications can only be submitted to hospitals).
· Create a new computerized system in the MoH, enabling an interface with the medical center’s systems and facilitating communication.
· Established an Israeli public registry and database of clinical trials (updated by the sponsors, as in: “clinicaltrials.gov”).
· Increased trend of investments by commercial companies 
· Achieved more transparency

In the future we intend to:
· Continue investment in creating optimal conditions for sponsors and industry, in order to attract innovative and qualitative medical research to Israel.
· Improve the efficiency of approval process of pharmacogenetic/ pharmacogenomic studies.
· Establish a national committee for the approval of multi-center studies.
· Create a basic uniform commercial contract between medical centers and sponsors.
· Conduct round-table discussions – a framework for cooperation between the Health and Economy Ministries, with a national overview.
· Develop big data studies
· Promote a Regulatory-Advice Plan

We expected in this way to increase the growth rate of the number of clinical trials conducted in Israel, and to brand Israel as a significant player in the developing international competition of R&D activity in the life sciences industry. It is further expected that the shorter clinical trial approval times, improved preparation and guidance given to the companies and improved transparency of the process will increase the likelihood that Israeli companies will position their activity in Israel and thereby contribute to the realization of the growth potential in this field.