China Marketing Authorization Holder (MAH)

Unlike the EU and US where individuals can be MAHs, in China, it can only be a legal entity like a pharmaceutical company or a research institution.

The MAH plays a crucial role by taking responsibility for the entire lifecycle of a drug in China, from obtaining marketing authorization (think of it as official approval to sell the drug) to ensuring its safety and quality throughout its time on the market. This includes overseeing manufacturing, distribution, and potential post-marketing safety monitoring.

So, the MAH is the accountable entity for the drug’s journey in China, ensuring it meets all regulatory requirements and reaches patients safely.