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Marketing Authorization Holder

Meaning

A Marketing Authorization Holder (MAH) is the legally designated entity, typically a pharmaceutical company or manufacturer, that is responsible for the quality, safety, and efficacy of a medicinal product placed on the market in a specific jurisdiction. The MAH holds the formal permission granted by a regulatory body, such as the FDA or EMA, to commercialize the drug. This legal designation carries the ongoing responsibility for pharmacovigilance, product information updates, and compliance with all regulatory standards throughout the product’s lifecycle.
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How Do Chinese Regulatory Bodies Oversee Compounded Hormone Preparations?

How Do Chinese Regulatory Bodies Oversee Compounded Hormone Preparations?

Chinese regulatory bodies, primarily the NMPA, implement a comprehensive framework, including MAH and GMP systems, to ensure the safety and quality of compounded hormone preparations, safeguarding individual physiological balance.
∞ National Medical Products Administration
∞ Compounded Hormone Preparation
∞ Good Manufacturing Practice
HRTio
August 25, 2025