Abstract :
Aim: Regulatory affairs in the pharmaceutical industry act as a vital bridge between global health authorities and pharmaceutical companies, ensuring that medicines and medical devices are safe, effective, and of high quality. The field emerged from historical tragedies, such as the sulphanilamide and thalidomide crises, which prompted the establishment of strict regulatory frameworks worldwide. Regulatory professionals oversee documentation, drug approvals, clinical trials, and compliance with Good Manufacturing Practices (GMP), thereby safeguarding public health while fostering innovation. In India, the Central Drugs Standard Control Organization (CDSCO) plays a pivotal role, alongside global counterparts such as the FDA (USA), EMA (Europe), TGA (Australia), and PMDA (Japan). Medical devices, regulated under global and national frameworks, are classified by risk level, with oversight ensuring quality, safety, and efficacy. While regulations continue to evolve, challenges in harmonization and the need for stronger international collaboration remain. Looking ahead, regulatory affairs will be increasingly crucial in addressing advances in medical technology, improving oversight, and strengthening patient safety standards across pharmaceuticals and medical devices.