Georgia: A Promising Destination for Clinical Trials

With its population of about 4 million people, and its location at the intersection of Eastern Europe and Western Asia, Georgia is one of Europe’s hidden treasures — except in the Clinical Trials field, of course.

It’s no secret that Georgia is an extremely attractive country in which to conduct research — developed legislation, short permit times, international integration and adherence to international standards — it’s a no-brainer. Ranked in seventh place in the World Bank’s Ease of Doing Business index, Georgia is right up there as a world leader in business across the board, including its pharmaceutical industry.

According to CRO, Global Clinical Trials, there are about 70 pharma manufacturers in Georgia. The country imports from 92 foreign manufacturers and exports to locations including Ukraine, Central Asia, Bulgaria and others.

Pharma news website, pharmaceutical-tehnology.com, tells us that more than 100 clinical trials were initiated in Georgia from 2020 to 2021 — a significant number for a country of its size. The country is home to 172 registered investigational sites and, crucially, has potential to accommodate further growth.

Source: gctrials.com

The State Of The Nation

Measures taken by the Georgian government in recent years contribute hugely to this positive state of affairs. Since 2013, the Georgian government has embraced a publicly financed universal healthcare programme that offers healthcare to the entire population which includes modern hospitals and healthcare facilities and access by citizens to private medical facilities. The introduction of this programme aimed to provide government-sponsored healthcare to the population and boost the development of healthcare facilities. 

Attractive Imports

State measures contribute hugely to Georgia’s further integration into the international pharmaceutical market — in Georgia, there’s no VAT on investigational products, no tax on imports and no requirement for licensing of imports and exports. Also, parallel import of certain varieties of already registered drugs is allowed. This all serves to increase the country’s attractiveness as a market with opportunities both for local supply of clinical trials and for import-export operations with drugs, equipment and consumables.

High Standards

GMP certification for manufacturers became mandatory from January 1st, 2022 and GDP certification for all distributors of medicinal products is compulsory from June 30th of the same year. For Clinical Trial sponsors, these innovations are intended to inspire confidence in the entire supply chain of purchased goods from production stage as well as in the quality of the products supplied, regardless of local or international supply. 

Open Markets, Favourable Conditions

The start of 2022 saw the opening of the Turkish market, allowing high-quality, GMP-standard drugs into Georgia along with the USA, Japan and the EU. These are measures which, according to the Georgian Ministry of Health, could allow a threefold reduction in drug prices on the market as a whole and also increase Georgia’s attractiveness as a market for local as opposed to centralised procurement of clinical trials. In addition, a simplified admission regime has been introduced for medicines from countries with high regulatory requirements, making the import and circulation of medicines in Georgia an attractive prospect. 

Ease of Regulation

Georgia has no registration procedure for medical devices (save for diagnostic tests, certain reagents and dental products). Permission related to product classification from the Georgian Ministry of Health is required prior to import and marketing.

Negotiation Opportunities

Negotiation on price is often a possibility with manufacturers when it comes to the supply of large volumes of clinical trial drugs as opposed to prices for commercial circulation.

COREX Logistics CEO Andrey Tarakanov observes that “the drug development industry is in a season of change; however, with change comes opportunity and with comprehensive government support and forward-thinking, the future’s bright here. The production of safe and effective treatments for patients certainly has a good home in Georgia”.