Chapter 6 - Regulatory requirements of regulated market

Abstract

The pharmaceutical industry is the most strictly regulated industries worldwide, with the government imposing several rules and regulations to protect the public’s health and well-being. One of the most critical issues for regulatory authorities is to ensure that pharmaceutical products are made in compliance with the country’s regulatory requirements. The process in the medicine development is a protracted journey, and eventually, the goal is to absorb the approval of new medicinal product for global requirement. The approval for marketing and distributing the pharmaceutical products in a regulated market is governed by the principles laid down in the guidelines termed as “marketing approval” or “registration,” “marketing authorization,” or “product licensing.” Common Technical Document (CTD) and electronic Common Technical Document are integral parts of the dossier, designed to provide a format common for Europe, the United States, and Japan. The other countries such as India, Australia, Canada, and Denmark also follow the CTD with diminutive variations for the same. To meet the mutually beneficial objectives of the industry and the regulatory body, a liaison between both the parties is essential. This chapter deals with detailing and comparison of marketing and distribution approval process in various countries.