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The drug Marketing Authorization Holder (MAH) system is a highlight in China's revised Drug Administration Law. One of the breakthroughs the MAH system has brought to China's pharmaceutical industry is that a drug marketing authorization holder no longer has to be the manufacturer. Since the law took effect in 2019, the MAH system has been implemented on every pharmaceutical companies seeking drug registration in China. Hence, it is necessary for pharma companies pursuing development in the Chinese market to know the MAH system, which is discussed in this article. Article Contents MAH's Definition Requirements for Becoming an MAH MAH's Rights MAH's Responsibilities Regulations on MAH Entrusting Product Manufacturing to Others Transfer of Marketing Authorization (MAH Change) Documentation Requirements for MAH Change Impacts of MAH System on International Companies in the Chinese Market BaiPharm Offers MAH Consulting Services to International Companies.

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