Case Study

From reforms to research: Georgia's journey to becoming a clinical trials hub

Georgia has emerged as a promising destination for clinical trials, with its economic and healthcare reforms since 1991 creating a favorable environment for research. The country, with a population of approximately 3.71 million as of 2022, offers a combination of high economic freedom and a restructured healthcare system that aligns with international standards, including full compliance with ICH GCP guidelines. According to WHO, Georgia hosted 103 active clinical trials, notable for its population size.

Clinical Trials Environment

Georgia stands out as interesting location for clinical trials, thanks to its streamlined and efficient approval process that remarkably spans only two months. This expedited pathway significantly enhances the pace at which research can commence. When it comes to financial considerations, Georgia offers a distinct advantage, with costs that are markedly lower than those found in the United States and Western Europe, providing an economical solution for clinical research. The country is also known for its broad spectrum of research opportunities, particularly excelling in the fields of cardiovascular and neurological disorders.

The regulatory framework is streamlined, with the LEPL regulation Agency for Medical and Pharmaceutical Activities overseeing clinical trials. Key documentation requirements are simplified, and although some documents need to be translated into Georgian, the process is designed to be straightforward and efficient.

Beyond these practical benefits, the quality of clinical data from Georgia is esteemed by leading global regulatory agencies, such as the FDA and EMA, a testament to the country's rigorous adherence to international research standards.

Opportunities Await

Georgia's healthcare system has evolved, with a notable increase in specialized clinics since 2000, enhancing its capacity for clinical trials. This, combined with the fast and simplified regulatory environment, positions Georgia as an attractive location for clinical trials, offering quality, efficiency, and cost-effectiveness.

Clinical trial approval milestones in Georgia

One of the shortest regulatory timelines on the market
Highly qualified staff
Geographical location
Strong clinical trial market landscape
High quality logisctic landscape
Lower cost