Published Paper Details:

Drug Regulatory Affairs (DRA) is essential to guaranteeing their effectiveness, safety, and quality. Drug regulation must change to accommodate new technologies like biotechnology, nanomedicine, gene therapy, and biosimilars as the pharmaceutical industry changes due to quick scientific breakthroughs. The USFDA, EMA, CDSCO, MHRA, PMDA, and TGA are just a few of the key regulators that are highlighted in this thorough review of the world's drug regulatory systems. Additionally, it looks at how the International Council for Harmonisation (ICH) has contributed to regulatory convergence by establishing uniform standards for efficacy, safety, and quality. The paper also goes into detail on different drug approval regulatory paths, including IND, NDA, ANDA, BLA, biosimilar approvals, fast-track authorizations, and emergency use authorizations. Special focus is paid to generic medications, biosimilars, and interchangeability principles, which greatly affect healthcare affordability and accessibility. The issues encountered by regulatory authorities--such as rising complexity of clinical trials, worldwide harmonization gaps, ethical concerns, and delays in approvals--are critically reviewed. The report delves deeper into the future of drug regulation, forecasting a move towards Blockchain-enabled supply chain monitoring, digital regulatory systems, AI-assisted assessments, and adaptive clinical trial designs. In general, the study highlights how crucial robust regulatory regimes are for advancing public health, fostering innovation, and guaranteeing that everyone has access to safe and effective medications.