Abstract

FIRST REQUIREMENT FOR THE APPEAL OF ANTICANCER DRUG SUBMISSION PROCESS IN USA & EUROPE

Medicinal products, pharmaceuticals, veterinary medicines, medical devices, and food supplements - all these products are subject to regulations designed by governments to protect public health. The Regulatory Affairs department ensures that their companies comply with all of the regulations and laws concerning their business. The Regulatory Affairs department is an important part of the organizational structure of pharmaceutical companies. Internally it liaises at the interphase of drug development, manufacturing, marketing and clinical research. Externally it is the key interface between the company and the regulatory authorities.