STUDY OF DRUG REGULATORY APPROVAL PROCESS AND COMPARATIVE REQUIREMENT OF COMMON TECHNICAL DOCUMENTS (CTD) IN EUROPE, US AND INDIA IN COORDINATION WITH DRUG DEVELOPMENT PROCESS

The pharmaceutical industry is one of the most highly regulated sectors in the world, owing to its direct impact on human health and safety. The development and commercialization of medicinal products require strict compliance with regulatory standards to ensure that drugs reaching the market are safe, effective, and of consistent quality.[1] Regulatory authorities across the globe have established comprehensive frameworks governing every stage of a drug’s life cycle, from early discovery and pre-clinical testing to clinical development, marketing authorization, and post-marketing surveillance. These regulatory systems not only protect public health but also promote scientific integrity, ethical conduct of clinical trials, and transparency in pharmaceutical manufacturing and distribution. Drug development is an inherently complex, lengthy, and resource-intensive process. On average, it takes more than ten years and substantial financial investment to bring a new drug from laboratory discovery to the patient’s bedside. The process typically includes target identification, lead optimization, pre- clinical pharmacology and toxicology studies, phased clinical trials, scale-up manufacturing, and regulatory submission. At each of these stages, regulatory requirements shape the design of studies, selection of endpoints, validation of analytical methods, and documentation of results. Therefore, regulatory science has become an integral component of pharmaceutical research and development, influencing decision-making and strategic planning throughout the product life cycle.[2]