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Regulatory Sovereignty

Meaning

Regulatory sovereignty, in the context of hormonal health, refers to the inherent authority of a nation-state or a defined governmental body to establish, interpret, and enforce its own unique set of laws, guidelines, and standards governing the production, prescribing, and dispensing of endocrine therapies. This principle acknowledges that regulatory frameworks are not globally uniform, leading to significant variations in drug availability, compounding rules, and accepted clinical practice across different international jurisdictions. It is a critical concept for international pharmaceutical commerce and clinical operations.