CT Legislation Sri Lanka | Resources Library

Sri Lanka has a robust regulatory framework for the conduct of clinical trials, ensuring the protection of participants' rights, safety, and well-being. The primary legislation governing clinical trials in Sri Lanka is the National Medicines Regulatory Authority (NMRA) Act. The NMRA oversees the approval, registration, and monitoring of clinical trials in the country.

To conduct a clinical trial in Sri Lanka, researchers and sponsors must obtain ethical clearance from an Ethics Committee (ERC) recognized by NMRA and regulatory approval from the NMRA. The ERC carefully reviews study protocols, informed consent forms, and other ethical considerations to ensure compliance with international standards and guidelines.

The regulatory requirements in Sri Lanka encompass various aspects of clinical trials, including trial design, participant recruitment, informed consent, data management, and safety reporting. Adherence to Good Clinical Practice (GCP) guidelines is mandatory, ensuring that trials are conducted with integrity, ethical principles, and scientific rigor.The regulatory requirements in Sri Lanka encompass various aspects of clinical trials, including trial design, participant recruitment, informed consent, data management, and safety reporting. Adherence to Good Clinical Practice (GCP) guidelines is mandatory, ensuring that trials are conducted with integrity, ethical principles, and scientific rigor.

Overall, Sri Lanka's clinical trials legislation provides a strong regulatory framework that promotes ethical research, patient safety, and the advancement of medical knowledge. Researchers and sponsors can confidently pursue clinical trials in Sri Lanka, knowing that their studies are conducted in compliance with internationally recognized standards.

Sri Lanka's Regulatory Framework for Clinical Trials