Navigating the Regulatory Maze: The Vital Role of Regulatory Affairs in Pharmaceutical Safety and Quality

Abstract

The real struggle of pharmaceutical industries for survival lies in performing processes by following the guidelines of various regulatory authorities around the globe to provide assured quality of the process under regulations [1]. A profession under-regulated industry, such as that controlling pharmaceuticals, medical devices, energy, and banking, is called Regulatory Affairs (RA) [2]. They may involve minor or major multinational corporations, including innovative biotechnology companies, which have a specific meaning and a separate specialized depart-ment of RA professionals. This department helps to guide the company on the regional and global laws and regulations set forth by different regulatory authorities and helps safeguard the products’ life cycle. The purpose of regulatory departments or pro-fessionals is to develop and promote heavily controlled therapeutic or pharmaceutical goods and build a platform for marketing approval. In addition to this, RA in the pharmaceutical industry is comparatively a new field to safeguard public well-being by monitoring the safety and efficacy of the products [3]. Furthermore, in the late 1950s, multiple tragedies resulted in an increase in legislation for pharmaceutical goods’ quality, safety, and efficacy. As a part of this, strict norms were made for Marketing Authorization (MA) and Good Manufacturing Practice (GMP) [4]. These tragedies included (i) sulphanilamide elixir; (ii) vac-cine tragedy; and (iii) thalidomide tragedy [4]. The present article covers the regulatory affairs’ responsibilities and importance in the context of pharmaceutical industries.