---
title: "Clinical Trial Approval"
url: "https://legal.ge/en/service/healthcare-and-pharmaceutical-law-en/clinical-trial-approval-en"
field: "Healthcare & Pharmaceutical Law"
description: "Articles 5¹, 12 and 37² of the Law on Drugs: clinical trial permit, sponsor insurance, fine of 4 000–8 000 lari. Legal.ge."
reviewed: "2026-02-13"
updated: "2026-10-19"
publisher: "legal.ge"
---

# Clinical Trial Approval

> Source: legal.ge, https://legal.ge/en/service/healthcare-and-pharmaceutical-law-en/clinical-trial-approval-en

## 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.

The full text is available on legal.ge after signing in: https://legal.ge/en/service/healthcare-and-pharmaceutical-law-en/clinical-trial-approval-en

### Under what rules are clinical trials conducted in Georgia?

Preclinical and clinical research into pharmacological agents is conducted in accordance with the standards and guidelines approved by the Minister and is subject to a permit.

### Who protects the participants of a trial?

The rights of patients and healthy volunteers are protected by the legislation of Georgia, and the sponsor must, before the trial begins, secure insurance for the duration of the research.

### What happens if a trial runs without a permit?

An unpermitted clinical trial is punished with a fine of 4 000 lari, and on repetition — 8 000 lari.

### May an unregistered product be manufactured for a trial?

Yes, only for the purposes of registration, research and export, with the Agency's permit and with the manufacturer bearing responsibility for the product's safety, quality and efficacy.