Georgia

Regulatory

Georgia has become an attractive region for clinical trials due to the recent development of the country’s healthcare system, as well as one of the shortest CTA review timelines within Europe. With full harmonization of the country’s legislation with international requirements, it takes less than 2 months to obtain a clinical trials (CT) approval while the CT data quality is high. The peculiarities of CT organization in Georgia include the need for LEC approval (3-4 weeks) before submitting documents to regulatory authorities (LEPL Agency for Regulation of Medical and Pharmaceutical Activities, the approval period is 3-5 weeks). There is no need to obtain import/export licenses for study drugs, laboratory kits and biosamples (a letter of authorization and a certificate from the regulator are sufficient).

Official links

https://www.moh.gov.ge

Pharmaceutical Industry & Clinical Trials Market

The country of Georgia for many years have been a location for clinical trials due to some distinct advantages. As a small country with a population of about 4 million, it allows a relatively easy recruitment of patients, many of whom are treatment-naïve. Many local and global companies conduct clinical research in Georgia due to numerous advantages the country has to offer:

• Full compliance with the ICH- GCP
• Clear regulatory requirements and a simplified process of documents submission
• The import license is not required. RA State Certificate is used for custom clearance
• High quality of data inspected and accepted by EMA and FDA
• Quick Regulatory Start-up. It takes only 2 months to initiate a study
• Qualified medical and clinical sites with experience in clinical studies
• Highly motivated investigators, site teams and patients
• Recognized International standards for disease treatment and prevention

There are about 70 pharma manufacturers in Georgia. The share of local companies among the total sales of pharmaceuticals is about 13 percent. The country imports drugs from 92 foreign manufacturers and exports to Ukraine, Russia, Central Asia, Belarus, Bulgaria and 12 other countries. The market is mainly regulated by the State.

Medical System in Georgia

Tbilisi and other major cities have medical centers of the highest standard. Since 2013, the Georgian government has embraced a new publicly financed universal healthcare program that offers healthcare to the entire population. This program offers various benefits including primary and secondary care services and some essential medicines. The state funds the country’s universal healthcare system. Citizens also have access to the private medical facilities. The introduction of the universal health care program in 2013 was aimed at providing government-sponsored healthcare facilities to the Georgian population and boosting the development of health care facilities. The Social Service Agency (SSA) is responsible for purchasing publicly financed medical care services. In the last decade, many qualified, well-structured modern hospitals and health centers have been established in Tbilisi. Every medical care provider in Georgia functions under control of the Ministry of Labor, Health and Social Affairs.