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Pharmaceutical Regulation

Meaning

The complex set of governmental laws, rules, and administrative processes that oversee the development, testing, manufacturing, labeling, marketing, and distribution of medicinal drugs. This regulatory framework is established to ensure the efficacy, safety, and quality of pharmaceutical products available to the public. For hormonal therapies, these regulations govern everything from the purity of active pharmaceutical ingredients to the clinical claims made in patient information. Compliance with these mandates is essential for all entities in the drug supply chain.