The Legal Framework for Approving a Clinical Trial
A clinical trial of a pharmacological agent in Georgia is never a purely technical or medical undertaking: it is fully regulated by the Law of Georgia on Drugs and Pharmaceutical Activities. Article 5¹ of the law governs preclinical and clinical research and provides that such research in Georgia is conducted in accordance with the standards and guidelines approved by the Minister. Before a single participant is enrolled, the sponsor therefore needs to know exactly which documentary framework will govern the review of the trial and what obligations the law attaches to initiating it.
Starting a clinical trial requires a permit, and conducting research without one is treated by the law as unlawful pharmaceutical activity punishable by a fine. For the organiser, this makes the preparation stage decisive: the ministerial standards, the permitting procedure and the protection of participants' rights must all be assessed together before the decision to launch is taken. Skipping any of these components exposes the sponsor both to administrative liability and to the loss of the trial's evidentiary value.