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).