Published Paper Details:

A key component of contemporary pharmaceutical governance is Drug Regulatory Affairs (DRA), which guarantees that medications entering the healthcare system are safe, efficient, and produced in accordance with strict quality standards. The regulatory environment now covers complex medicines including biologics, biosimilars, cell and gene therapies, nanomedicine, and digital therapeutics, going well beyond standard drug control as scientific discovery picks up speed. The development, composition, and future course of international drug regulatory regimes are all thoroughly assessed in this research. The structure and importance of DRA are thoroughly explained in the outset, and then important historical occurrences that influenced regulatory policy are examined. To illustrate differences and convergence in global systems, the functions of significant international authorities such as the FDA, EMA, CDSCO, PMDA, MHRA, and TGA are studied. A thorough examination of ICH harmonisation emphasizes how important it is for creating common technical and scientific standards. Global inconsistency, complicated clinical ethics, data integrity issues, fake medications, and regulatory capacity limitations are some of the current issues that are criticized. The research also examines the vital role of international cooperation, including harmonized inspection systems, mutual recognition agreements, and collaborative evaluations. The future scope places a strong emphasis on Blockchain-based supply chains, digital transformation, AI-enabled regulatory evaluations, adaptive trial designs, and the slow transition to unified global frameworks. All things considered, this analysis emphasizes how crucial strong, open, and flexible regulatory frameworks are to safeguarding public health while also promoting innovation and fair access to life-saving medications.