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.
Sponsor Insurance in Phase I
Before the start of a clinical trial the sponsor — the person, company, institution or organisation responsible for the initiation, management or funding of the research — secures insurance of the trial's risk and liability for the duration of its conduct. The insurance must provide for the reimbursement or compensation of the treatment costs of the participant or participants incurred in connection with their participation. In phase I, where the participant is healthy, this insurance is the principal financial instrument of his or her protection.
Manufacturing the Trial Product and Liability
The product needed for a phase I trial is often unregistered in Georgia. The twelfth article of the law makes this possible: the manufacture of an unregistered pharmaceutical product in Georgia is allowed for the purposes of its registration, preclinical and clinical research, and export. Manufacturing is subject to a licensing regime, the permit is issued by the Agency, and the manufacturer of the series is responsible for the product's safety, quality and efficacy.
Operating without a permit is punished at this stage of research as well: conducting a clinical trial of a pharmacological agent without a permit — like unlicensed manufacturing, the import or export of a specially controlled product without a permit, or operating an authorised pharmacy without one — entails a fine of 4 000 lari, and on repetition a fine of 8 000 lari. These consequences are established by Article 37² of the law and apply fully to the organiser of a phase I study.
Frequently Asked Questions
Which studies may be conducted on healthy volunteers in Georgia?
A bioequivalence study of a medicinal product, a pharmacokinetic study of a pharmacological agent developed in Georgia, and a study permitted on a recognised foreign market that is conducted on healthy volunteers.
What does the law require for research into advanced therapy agents?
Such research is permissible only if the agent is manufactured under a good manufacturing practice standard recognised by the Government, at an enterprise holding the authorisation to manufacture biological medicinal products.
Who arranges the insurance of a phase I trial?
Insurance is the sponsor's duty: before the trial begins it must secure insurance for the duration of the research, reimbursing or compensating the volunteer's treatment costs.
What fine threatens an unpermitted start of a phase I trial?
Conducting a clinical trial without a permit is punished with a fine of 4 000 lari, and on repetition with 8 000 lari. The same liability extends to unpermitted manufacturing and import-export.
How We Help on Legal.ge
Phase I trial approval begins with the additional requirements connected with healthy volunteers. On Legal.ge we help you determine the permissible type of study, resolve the sponsor's insurance and manufacturing issues, and assess the risk of fines. Contact us — we will put your research on a sound legal footing from the outset.