Clinical Trial Approval and Permitting Procedures in Georgia
Georgia is becoming increasingly popular for international clinical trials due to its transparent regulatory environment and qualified medical personnel. However, obtaining state permission before starting a trial is mandatory, involving a complex legal and administrative process. Clinical trial approval requires a two-step validation: ethical assessment by an independent Bioethics Committee and official permit issuance by the Regulation Agency for Medical and Pharmaceutical Activities. Any inaccuracy or documentation flaw in this process leads to application rejection, significantly delaying the trial start and increasing financial costs for the sponsor.
Legal.ge offers full legal support in the clinical trial approval process. Specialists on our platform ensure communication with the regulatory body, preparation of documentation, and its adaptation to local legislation. Our goal is to minimize bureaucratic barriers and ensure timely receipt of the permit so you can focus on the scientific aspects of the research.
What Does Clinical Trial Approval Service Cover?
Our lawyers offer a complete service package covering all details of the permitting process:
- Documentation Audit and Preparation: Legal review of the Study Protocol, Investigator's Brochure, CRF (Case Report Form), and other technical documents.
- Informed Consent (ICF) Adaptation: Translating and adapting the Patient Information Sheet and Consent Form according to Georgian legislation and ethical norms.
- Working with Bioethics Committees: Preparing and submitting the application to an accredited Ethics Committee, answering queries, and obtaining a positive opinion.
- Submission to Regulatory Agency: Submitting the full package (including insurance policy and agreements) to the Regulation Agency for Medical Activities.
- Deficiency Resolution: Promptly responding to comments from the Agency or Ethics Committee and submitting corrected documentation.
- Management of Amendments: Handling the approval procedure for substantial changes to the protocol during the trial.
Common Situations and Scenarios
A frequent scenario involves an international sponsor providing English documentation that is directly translated into Georgian without considering legislative nuances. For example, an insurance policy might not cover specific risks required by Georgian law. In such cases, the Agency suspends the review. A lawyer checks the policy in advance and requests corrections before submission.
Another common situation relates to investigator qualification. The Agency requires proof that the Principal Investigator has appropriate experience and certification (GCP). The lawyer assists the research center (Site) in correctly compiling personnel documentation (CVs, certificates) to avoid permit delays due to staffing issues.
Georgian Legislation and Legal Framework
The clinical trial approval process is regulated by the Law of Georgia on Medicines and Pharmaceutical Activities (Chapter on Clinical Trials). Detailed procedures are defined by orders of the Minister of Internally Displaced Persons from the Occupied Territories, Labour, Health and Social Affairs. The process is fully compliant with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) standards. For ethical assessment, committees are guided by the Declaration of Helsinki and the Law on Patient Rights.
Process of Receiving Services
Cooperation begins with signing a Non-Disclosure Agreement (NDA). Then, Legal.ge specialists receive the core trial documentation and conduct a preliminary assessment (Feasibility). Following this, document translation and notarization begin. In parallel, the lawyer works with the Ethics Committee and on finalizing agreements with the clinic. Once a positive opinion from the Ethics Committee is received, the full package is sent to the Agency. Upon receiving the permit, the lawyer hands over the official document to the client, concluding the approval stage.
Trust Legal.ge's experience to ensure your trial starts on time, in full compliance with the law, and without unnecessary bureaucratic headaches.
Why Choose a Specialist on Legal.ge?
Clinical trial regulation is a niche field. A general profile lawyer might miss nuances such as specific insurance requirements for Adverse Events (AE) or ethical aspects of informed consent. Legal.ge gives you access to experts who have direct experience working with the Agency and know how to accelerate the process through legal means.
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