A Thorough Study of the Updated Regulations Governing Drug Trials in India, Ghana, Singapore and Tanzania

Abstract

Clinical trials are crucial stages in the development of a novel pharmaceutical product for commercial launch. The studies are meticulously crafted to evaluate the safety and effectiveness of a new medicine in human participants. The procedure typically involves multiple steps, such as: Preclinical testing, Phase 1, Phase 2, Phase 3 and Phase 4 Clinical Trials, or Post-Marketing Surveillance. Strict regulations and moral standards are implemented at every phase of clinical trials to protect the rights and well-being of participants. The requirements include obtaining informed consent from participants, according to Good Clinical Practice (GCP) guidelines, and oversight by institutional review boards (IRBs) or ethical committees. A questionnaire was created and distributed to different stakeholders of the healthcare team in the current research. The questions focused on the New Drug Trial Rules and compared regulations across different nations to assess the advantages and disadvantages of each country's legislation on clinical trial studies in order to identify areas for improvement. Significant conclusions were made from the questionnaire.