Clinical Trials Law is a highly specialized field regulating the process of testing new medications and medical technologies on humans. In recent years, Georgia has become an attractive hub for international pharmaceutical companies to conduct clinical trials, increasing the demand for qualified legal support. This process is strictly regulated to protect the safety and rights of trial subjects (patients) and ensure data reliability. Starting a clinical trial requires permission from the regulator, approval from an ethics committee, and managing complex contractual relationships between the sponsor, research center (clinic), and investigator.
Specialists on Legal.ge offer full legal support at all stages of clinical trials:
- Regulatory approvals: Preparing and submitting documentation packages to the Regulation Agency for Medical and Pharmaceutical Activities to obtain permits.
- Ethics committee support: Communicating with the bioethics committee and justifying the ethical aspects of the trial protocol.
- Contract management (CTA): Drafting and negotiating Clinical Trial Agreements between the sponsor and the clinic.
- Patient informed consent: Legal audit and adaptation of Informed Consent Forms (ICF) to Georgian legislation.
- Data protection and GDPR: Ensuring personal data protection during the trial, especially regarding international transfers.
In practice, one of the biggest challenges is insurance for trial participants. The law requires all subjects to be insured against trial-related harm. A lawyer ensures the insurance policy is valid and covers real risks. Disputes over intellectual property are also common — who owns the data obtained during the trial? A well-drafted contract avoids these misunderstandings. Additionally, amendments to the protocol are frequent during the trial, requiring prompt legal formalization.
In Georgia, clinical trials are regulated by the Law "On Medicines and Pharmaceutical Activities" and the Minister of Health's order "On the Rule of Conducting Clinical Trials." These regulations are based on international Good Clinical Practice (GCP) standards. Violating them leads to trial suspension and invalidation of data, meaning millions of dollars in losses for the sponsor.
Working with a specialist begins at the trial planning stage. The lawyer checks if the selected clinic and investigator meet statutory criteria. They also provide legal support for the import and export of trial materials (investigational drugs).
Legal.ge is your guide through the complex labyrinth of clinical trials. Our experts are familiar with both local regulations and international requirements, guaranteeing that your trial will be conducted smoothly and legally.
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