OVERVIEW OF DRUG REGULATORY AFFAIRS AND ROLE OF REGULATORY AFFAIRS IN A PHARMACEUTICAL INDUSTRY

Abstract

The regulatory affairs (RA) team is dedicated in the pharmaceutical industry because they are concerned about the healthcare system lifecycle of a product. They offer strategic, tactical, and operational guidance and assistance in order to speed the design and deployment of secure and efficient medical supplies to people all over the globe while adhering to laws. The position of regulatory affairs is to develop and enforce a regulatory strategy to assure that the drug research group's collective work yields an outcome that is endorsed by global regulators but also stands out from the competition in some way, as well as to assure that the company's actions, from non-clinical research to advertising and marketing, are carried out in compliance with regulatory rules and policy.In the pharmaceutical industry, drug regulatory affairs are a critical unit. Because the pharmaceutical industry is continually growing, regulatory affairs specialists are in high demand to meet the current demands of companies in order to compete globally. Executives in drug regulatory affairs serve as a vital link between the pharmaceutical industry and international regulatory organizations. The approval of pharmaceutical products should be a vital step in ensuring that people have access to safe and effective medications. India's Central Drugs Standard Control Organization (CDSCO) has opted for using the CTD structure for technical criteria for drug registration.The use of CTD is intended to greatly decrease the amount of time and resources required by the industry to assemble global registration applications. A regulatory affairs professional is someone who serves as a link between pharmaceutical companies and government agencies all over the globe. The purpose of a regulatory affairs professional is to safeguard the wellbeing of people by guaranteeing drug safety, effectiveness, and quality, as well as assuring that product information is suitable and accurate. The emergence of regulatory affairs, its function in the pharmaceutical business, and its engagement in the application of regulatory rules that promote the sector’s expansion are all discussed in this section.

Keywords: Regulatory Affairs professionals, Regulatory agencies, Drug Approval Process, CTD Worldwide Regulatory Agencies.