Phase I Research in the Georgian Legal Order
A phase I clinical trial in Georgia is associated first of all with healthy volunteers, and this is precisely why its approval demands particular precision. Article 5¹ of the Law of Georgia on Drugs and Pharmaceutical Activities provides that preclinical and clinical research into pharmacological agents is conducted in accordance with the standards and guidelines approved by the relevant Minister, and that the start of research requires a permit. For the planner of a phase I study this defines the entire subsequent work — from the protocol to the reporting.
The law separately emphasises the protection of participants: the rights of patients and healthy volunteers participating in clinical research are protected by the legislation of Georgia. Research conducted on a healthy volunteer is exactly the case in which the participant receives no direct therapeutic benefit, which makes the legal guarantees especially significant here.
Which Studies Are Permissible on Healthy Volunteers
Article 5¹ lists the studies that are permissible in Georgia to conduct on a healthy volunteer. These are: a bioequivalence study of a medicinal product; a pharmacokinetic study of a pharmacological agent developed in Georgia; and a study permitted on a market subject to the control of a foreign or international state regulatory body for pharmaceutical products recognised under the legislation of Georgia, which is conducted on healthy volunteers.
This list is decisive for the planner of a phase I study: only these three types of research are permissible on healthy volunteers. A bioequivalence study compares the product's bioavailability against a reference form; a pharmacokinetic study describes the agent's behaviour in the body — and is permissible only for an agent developed in Georgia. Where the study is permitted on a foreign market, the fact of the regulatory body's recognition becomes essential.
Advanced Therapy and Prohibited Agents
If a phase I study concerns a pharmacological agent intended as an advanced therapy medicinal product, the law adds a condition: such research is permissible only if the agent is manufactured under a standard of good manufacturing practice recognised by the Government of Georgia, at an enterprise holding the authorisation to manufacture biological medicinal products.
Moreover, it is impermissible to conduct clinical research in Georgia using the individual products and means defined in the first article of the same law — this prohibition is not relaxed in any phase of research. When preparing the protocol, the planner of a phase I study must make sure that the agent to be used in the research does not fall under this prohibition.