FDA Harmonization Project – Aligning Standards


FDA Harmonization Project – Aligning Standards

One of the U.S.-Israel Science and Technology Foundation’s (USISTF) greatest successes in its mission to increase scientific development and strengthen economic relations is the U.S. Food and Drug Administration (FDA) Harmonization Project.  The project brought about the alignment of American and Israeli standards in the areas as Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP).

In 1996, the USISTF provided $100,000 in funding to train over four hundred Israeli medical professional at the Ministry of Health.  USISTF recognized the economic and social rewards of a simpler, more efficient clinical trials process.  Israel has been a favored site for clinical studies, owing to its diverse population base, loyalty to a single HMO and relative ease of patient tracking.  Historically, clinical studies in Israel have proven to be highly cost-effective, with high participant recruitment rates and much lower rate of patient drop out.  Moreover, Israel ranks first in the world in several therapeutic areas and boasts a high quality medical environment.
Thus, increasing the number of clinical studies conducted by U.S. pharmaceutical companies in Israel would create a clear benefit to both nations.

In 1997, the Food and Drug Administration granted Israel recognition as a site for complete data acceptance for clinical studies with trials conducted for new drugs and medical devices in Israel.  Israel’s popularity as a site for clinical studies, particularly by U.S. multi-national companies, has grown exponentially since then.  The USISTF’s investment in regulatory harmonization was a key element causing a boom of activity within the clinical trials industry; from a starting point of $15 million in net revenues in 1994, it had matured into a $300 million industry by 2005.

The Foundation’s FDA Harmonization Project has compellingly demonstrated the mutual benefit, in terms of health and economic welfare, which the U.S. and Israel can derive from collaboration between their governments, industry, and research institutions.  The opportunities and future potential of combined U.S. and Israeli endeavors in this particular industry are undoubtedly as great.