Abstract: For the pharmaceutical industry, Regulatory Affairs (RA) are crucial. While RA was initially established to facilitate the introduction of new products to the market, maintaining regulatory approval is as important as obtaining it. The aim of this review was to provide an overview of the role of RA in pharmaceutical industries and regulatory authorities, and to analyze the functions of various regulatory institutions in key developed and emerging nations, highlighting the challenges these organizations face in delivering healthcare services. This study emphasizes that the role of RA is vital during both the pre-development and postdevelopment phases of medicines, given the important role of medicines in health. RA serves as the interface between the regulatory agency and the project team, enabling effective communication. Regulatory provisions must be followed when drafting the project plan to ensure compliance and product clearance. RA has several key responsibilities, including ensuring compliance, obtaining approvals from various regulatory bodies, providing guidance on drug approval, and offering technical support to the Research and Development (R&D) and production departments. RA specialists operate at the intersection of business, law, and pharmacy, assessing whether regulations are being followed. The RA department plays a critical role throughout the pharmaceutical lifecycle, from the initial development of dosage forms to post-marketing activities. It also assists pharmaceutical companies in preparing regulatory strategies and compiling regulatory documents.
Khadul et al. (Wed,) studied this question.