An Ideal Environment – Clinical Trial Supply in Georgia

Georgia is a prominent player on the clinical trials map. According to centerwatch.com, there are currently 132 studies underway in the country. While this figure isn’t yet comparable with the number of studies conducted in the United States or China, it’s well worth noting that Georgia has the capacity to turn from a prominent player on the field into a leader in its region. 

Developed legislation, short timeframes for obtaining study approvals, integration into the international system of organizing clinical trials, and adherence to international standards all add up to a solid foundation for leadership and ease in clinical trial supplies for the ongoing studies. 

According to the Ease of Doing Business ranking published by the World Bank, Georgia ranks 7th, a position which implies favourable conditions for doing any business, including pharmaceuticals. 

Various state programs also actively contribute to developing the pharmaceutical business environment. For example, from January 1, 2022, a decree on mandatory GMP certification came into force. And from June 30, GDP certification is required for all distributors of medicinal products. Such innovations help to build confidence in the supply chain and ensure quality products from purchase to storage, making Georgia extremely attractive to sponsors of clinical trials. 

The opening of the Turkish market to Georgia at the beginning of 2022 led to the improvement of availability, price and diversity of presented medical products. According to the Georgian Ministry of Health, as of May 2022, these measures allow us to talk about a three-fold decrease in drug prices on the market as a whole. This certainly increases the attractiveness of the Georgian market for local rather than centralised sourcing for international clinical trials needs. 

In addition, the import and circulation of medicines has been improved by the introduction of a simplified admission regime for medications approved by countries with high regulatory requirements. There is now no VAT, no tax on imports, licensing of imports and exports has been cancelled, and parallel import of different variations of already registered packages of drugs  is allowed. 

On top of that there is no registration procedure for medical devices in Georgia (except for diagnostic tests, certain types of reagents, and dental products), and permission from the Ministry of Health is required to import and put them into circulation. 

It is also important to note that many manufacturers offer flexible solutions when it comes to large purchases of drugs needed for clinical trials. 

All of this allow us to consider Georgia as an optimal location for conducting clinical trials and local sourcing for clinical supplies of comparators, concomitant therapy drugs and ancillaries. At COREX, we've already seen the potential of the country – how about you?