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.
Manufacturing the Product Needed for the Research
A recurring practical question is how to obtain the product that has not yet been registered in Georgia. The twelfth article of the law answers this clearly: the manufacture in Georgia of an unregistered pharmaceutical product is allowed for the purposes of its registration, for preclinical and clinical research, and for export. At the same time, the manufacture of a pharmaceutical product is in general subject to a licensing regime, and the manufacturing permit is issued by the Agency.
Quality requirements for manufacturing are also set by the law: Georgia selectively recognises a list of international, regional and national good manufacturing practice standards, as recognised by the Government of Georgia. The person manufacturing a series of the pharmaceutical product is responsible for the safety, quality and efficacy of the product produced. This responsibility entails thorough documentation and verification for every research series, however small the batch produced for the trial.
Liability for Operating Without a Permit
Article 37² of the law establishes a fine for activity conducted without the required permit — namely pharmaceutical manufacturing, the export or import of a specially controlled pharmaceutical product, the operation of an authorised pharmacy, or a clinical trial of a pharmacological agent. Such conduct entails a fine of 4 000 lari. The same conduct committed repeatedly entails a fine of 8 000 lari.
A trial started without a permit therefore creates a double problem: the sponsor pays the fine, and the results of the research become unusable for the subsequent procedures contemplated by the same law. The fine doubles on repetition, so aggravating the violation generates further cost. Additional sanctions and measures are provided for by other norms of the law, and a comprehensive risk assessment before launch is markedly cheaper than dealing with the consequences afterwards.
Frequently Asked Questions
Who sets the standards for clinical trials in Georgia?
The standards and guidelines for preclinical and clinical research into pharmacological agents are established and approved by the relevant Minister. The research must be conducted in accordance with these standards; otherwise its results cannot serve as a reliable basis for further decisions on the product.
What fine follows from starting a trial without a permit?
Conducting a clinical trial without a permit entails a fine of 4 000 lari, and the same conduct committed repeatedly — a fine of 8 000 lari. This is provided for by Article 37² of the Law of Georgia on Drugs and Pharmaceutical Activities.
Who is the sponsor and why does the sponsor need insurance?
The sponsor is the person, company, institution or organisation responsible for the initiation, management or funding of the trial. The law obliges the sponsor, before the trial begins, to secure insurance for the duration of the research which reimburses or compensates the participants' treatment costs.
Can an unregistered product be manufactured in Georgia for research?
Yes. The law allows the manufacture of an unregistered pharmaceutical product for the purposes of registration, preclinical and clinical research, and export. Manufacturing remains subject to licensing, the permit is issued by the Agency, and the manufacturer of the series is responsible for the product's safety, quality and efficacy.
How We Help on Legal.ge
Approving a clinical trial demands an accurate account of the standards, the permit and the sponsor's obligations. On Legal.ge we help you build the legal framework for preparing the research, examine the insurance and manufacturing issues, and assess the risks connected with administrative fines. Contact us for a consultation — we will analyse your situation and give you concrete, applicable recommendations.