The pharmaceutical industry operates in a highly regulated environment, where adherence to various regulatory requirements is essential to ensure the safety, efficacy, and quality of drugs. Regulatory Affairs (RA) professionals play a crucial role in navigating the complex landscape of pharmaceutical regulations, which are subject to continuous evolution. This article provides an overview of the key aspects of pharmaceutical regulatory affairs, including drug development, regulatory submissions, clinical trials, post-marketing surveillance, and global harmonization efforts. It explores the challenges faced by regulatory affairs professionals and highlights strategies to effectively manage compliance and ensure successful regulatory outcomes.
The primary objective of pharmaceutical regulatory affairs is to safeguard public health by ensuring that pharmaceutical products meet the highest standards of safety, efficacy, and quality. Regulatory affairs professionals work diligently to ensure that drugs undergo rigorous testing, meet regulatory requirements, and gain approval for marketing and distribution.
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Pharmaceutical Regulatory Affairs: Open Access received 533 citations as per Google Scholar report
