Drug Regulatory Affairs (DRA), providing a comprehensive overview of its multifaceted landscape. Beginning with an exploration of the historical evolution and significance of DRA in the pharmaceutical industry, we traverse the global regulatory terrain, elucidating the roles of prominent agencies such as the FDA, EMA, and PMDA. The article meticulously outlines the drug development process, emphasizing key regulatory milestones at each stage, from preclinical studies to clinical trials and beyond. New Drug Application (NDA) and Marketing Authorization (MAA). The review underscores the critical role of comprehensive and compliant documentation in securing regulatory approvals. Moving into the clinical trial arena, we delve into the regulatory frameworks governing trials, addressing ethical considerations, informed consent, and the imperative of patient protection. Illuminates the critical role of Drug Regulatory Affairs in pharmacovigilance and drug safety, exploring Post-marketing surveillance and adverse events. Quality assurance and adherence to Good Manufacturing Practices (GMP) take center stage, offering insights into regulatory guidelines that ensure product quality and safety. Additional sections discuss the regulatory pathways for generic drugs and biosimilars, emphasizing the challenges and considerations inherent in obtaining regulatory approval for these products. Emerging trends in DRA, such as the impact of technology on regulatory processes and considerations for personalized medicine and gene therapies, are thoughtfully examined. Exploration of regulatory compliance, enforcement measures, and strategies for maintaining adherence. Through this holistic review, readers gain a nuanced understanding of the dynamic and ever-evolving landscape of Drug Regulatory Affairs.