Clinical Trial Law: Regulation and Authorization in Georgia
Georgia is an attractive location for international pharmaceutical companies to conduct clinical trials due to rapid regulatory procedures and data reliability. However, initiating and managing a trial requires strict adherence to complex legal requirements. Any clinical trial involving human observation or intervention is subject to state regulation. The Sponsor and the Contract Research Organization (CRO) must undergo a rigorous authorization process, demonstrate ethical compliance, and ensure adherence to Good Clinical Practice (GCP) standards.
Legal.ge offers legal services for clinical trial organizers and sponsors. Our platform's lawyers assist in effectively navigating regulatory barriers, obtaining permits, and ensuring the full legal compliance of the research process. This service focuses on the institutional and regulatory aspects of the trial, ensuring a smooth project launch and operation.
What Does Clinical Trial Legal Service Cover?
Our specialists provide support at all stages of trial administration and authorization:
- Obtaining Trial Permit: Preparing and submitting full documentation (Protocol, Investigator's Brochure, CRF) to the Regulation Agency for Medical Activities to obtain the permit.
- Interaction with Bioethics Committees: Submitting documents and communicating with independent Ethics Committees to obtain a positive opinion, which is a prerequisite for the permit.
- Site Selection and Contracting: Verifying the eligibility of medical institutions (license, infrastructure) and formalizing legal relationships with them.
- GCP Compliance Audit: Checking documentation and processes during the trial for compliance with Good Clinical Practice (GCP) standards.
- Import/Export of Medications: Legal support for customs procedures regarding investigational medicinal products and biological samples.
- Amendments: Informing the Agency and obtaining new approvals/consents when changes are made to the trial protocol.
Common Situations and Scenarios
A frequent scenario involves an international sponsor wishing to start a trial in Georgia, but the submitted documentation does not meet local requirements (e.g., the informed consent form is not adapted to the Georgian context). A lawyer localizes and aligns the documentation, avoiding rejection due to flaws. Issues with the Ethics Committee are also common, where the committee requests additional clarifications on patient safety. The lawyer helps the research team prepare a substantiated response.
Georgian Legislation and Legal Framework
The field is regulated by the Law of Georgia on Medicines and Pharmaceutical Activities (Chapter "Clinical Trial"), which establishes the permit issuance rules. The process must comply with the WMA Declaration of Helsinki and ICH-GCP international guidelines, which are recognized in Georgia. The Law on Health Care and Government decrees on bioethics norms are also significant.
Process of Receiving Services
The client (Sponsor or CRO) contacts a Legal.ge specialist before the project starts. The lawyer conducts a preliminary consultation regarding timelines and required documents. Then, the document package is collected, translated, and notarized. The lawyer submits the application to the Agency and monitors it until a response is received. After obtaining the permit, the lawyer remains an advisor until the trial concludes (Close-out visit) to ensure final reports are correctly submitted.
Through Legal.ge, you will find a partner who simplifies bureaucratic processes and ensures the legitimacy of the research.
Why Choose a Specialist on Legal.ge?
Clinical trial regulation is a niche and specific field. Errors can lead to trial suspension and huge financial losses. Legal.ge connects you with lawyers who have practical experience working with the Agency and Ethics Committees, guaranteeing process efficiency.
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