The importance of a regulatory science approach for better pharmaceutical regulation

Abstract

Although regulatory science has been recognized as an important field in the area of pharmaceutical regulation, it may be still immature and is likely to evolve further as science itself advances with an increasing accumulation of knowledge and experience. In real-life situations, the strength of evidence for each set of data and information used for regulatory assessment varies widely. Indeed, inconsistent results are not uncommon. Scientific, non-biased, and objective assessment based on all of the available data and information may pinpoint the truth and determine the value of science to society in advancing public health. From this perspective, regulatory science can be viewed as important for finding practical and up-to-date solutions for issues where there is a degree of scientific uncertainty and limitations. As such, regulatory science is invaluable for improving pharmaceutical regulation. The combined involvement of experts across a wide range of disciplines engaged in medical, pharmaceutical, statistical and technological sciences, as well as economics, jurisprudence, education, and other disciplines will be important in increasing research activities in regulatory science. Discussing each issue from various perspectives will be crucial in finding the best solutions. Continuous effort at the global level will be necessary for further developments of "regulatory science" that can be applied to various real-life issues in society.

Navigating the Regulatory Landscape: Key Trends Shaping Today's Regulatory Affairs Environment

“…(6) Typically, regulatory affairs involve the reactive application of established regulatory concepts to specific drug development or the drug life cycle, primarily focusing on compliance with regulations. (7) In contrast, regulatory Science is characterized as the proactive analysis of regulatory concepts and the pursuit of their evolution in alignment with ongoing scientific advancements. The "Change in Environment" megatrend encompasses factors like climate change and evolving public health concerns, impacting regulatory aspects:…”