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Regulatory Definition

Meaning

A Regulatory Definition is a precise, legally binding statement issued by a governmental or statutory body, such as the FDA or EMA, that establishes the official meaning, scope, or classification of a product, practice, or term within a controlled domain. These definitions dictate how a substance, like a hormone or a peptide, is classified as a drug, supplement, or cosmetic, which in turn determines the required manufacturing, testing, and marketing standards. Adherence to the regulatory definition is mandatory for all entities operating within the health, wellness, and pharmaceutical sectors. Understanding the specific regulatory definition is crucial for clinical translation and commercial compliance.