Regulatory Perspectives : Where We Came from, Where Are We Today, Where Are We Headed?

Abstract

While frequent employment of the phrase “regulatory science” by regulators and academics arose within the last three decades, “science” applied to “regulation” of medicinals dates back many centuries. Descriptive science characterized the earliest classifications of medicinal substances, employed for self-regulation by apothecaries and physicians. Later, development of chemical and biological techniques permitted more precise descriptions of biological and drug products, which were adaptable to development of quantitative product specifications for governmental regulation of manufacturers. Motivated by need to protect and support public health, advanced regulatory science has been applied to research regulatory standards and requirements. Advanced regulatory science is currently being researched and intensively applied in both medical product regulation and development. Ever more novel regulatory science is likely to contribute in a crucial way to undreamed of advances in pharmaceutical development and improved public health.