This thesis provides a comprehensive examination of the ethical and legal aspects of drug regulatory compliance through integrated analysis of theoretical frameworks, regulatory structures, empirical evidence, and case studies across major jurisdictions. The research traces the historical evolution of pharmaceutical regulation from basic adulteration prevention to comprehensive pre-market review and post-market surveillance, demonstrating how catastrophic incidents catalyzed regulatory reform. Ethical analysis reveals fundamental tensions between principles of non-maleficence, beneficence, autonomy, and justice that require value judgments extending beyond technical assessment.