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.
Standards Under Which the Research Is Conducted
The law states that preclinical and clinical research is conducted in accordance with the standards and guidelines — the so-called guidelines — for research into pharmacological agents, as approved by the Minister. In practice this means that the trial protocol, the rules for collecting data, safety monitoring and the documentation of results must each satisfy the requirements embedded in those standards. Deviation from the standards undermines the reliability of the results, and data obtained in this way cannot serve as a trustworthy basis for the subsequent registration of the product.
Under the same Article 5¹, the rights of patients and healthy volunteers participating in clinical research are protected by the legislation of Georgia. This guarantee follows every participant through all stages of the trial and rests on the general legal order established to protect life, health and personal safety. The organiser must deal with participants against the background of precisely this standard, not on the basis of its own internal policies alone.
The Sponsor and Insurance of the Trial Risk
The law defines the sponsor as the person, company, institution or organisation responsible for the initiation, management or funding of a clinical trial. It is the sponsor who bears the key pre-launch obligation: before the trial begins, the sponsor must secure insurance covering the risk and responsibility of the clinical research for the entire duration of its conduct. The insurance must provide for the reimbursement or compensation of the treatment costs of the participant or participants, to the extent that such costs were incurred in connection with their participation in the trial.
This insurance requirement is not a formality. For the participant it is the financial safety net that applies when health is harmed during the trial and treatment becomes necessary; for the sponsor it is the instrument that allocates the risk in advance, under a documented procedure. A sponsor without the required insurance has no right to start the trial at all, and launching it creates problems that arrive together with the fine.