TY - JOUR AU - Krishnasis Chakraborty AU - Kavita Yadav PY - 2018/09/15 Y2 - 2024/03/28 TI - Drug approval process in US, Europe and India and its regulatory requirements: A Review JF - International Journal of Drug Regulatory Affairs JA - Int J Drug Reg Affairs VL - 6 IS - 3 SE - Review DO - 10.22270/ijdra.v6i3.266 UR - https://ijdra.com/index.php/journal/article/view/266 AB - Current constrain of Regulatory Affairs reveals diverse countries need to follow different regulatory requirements for marketing authorization Application (MAA) approval of new drugs. In this present exertion, study expresses the drug approval process and regulatory requirements according to US Food and Drug Administration (UDFDA), European Medical Agency (EMA) and Central Drug Standard Control Organization (CDSCO) (1). ER -