Comprehensive Overview of Clinical Trial Regulations in the UK
Clinical Trial Regulations in the UK are designed to ensure the safety, rights, and well-being of participants while maintaining the scientific integrity of research. Governed by key legislation such as the Medicines for Human Use (Clinical Trials) Regulations 2004, the Medicines and Medical Devices Act 2021, and guidelines like Good Clinical Practice (GCP), these regulations provide a robust framework for conducting trials. Regulatory bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA) and Research Ethics Committees (RECs) oversee trial approvals, safety monitoring, and compliance. By adhering to these regulations, the UK fosters ethical, high-quality research and maintains its position as a leader in global clinical trials.
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