The drug marketing authorization holder (MAH) system is an internationally popular drug marketing and approval system. It is a system that is in line with the world.
The core of the MAH system is to separate the drug marketing license from the drug manufacturing license, allowing drug manu- facturers, R & D institutions or scientific researchers to become independent drug marketing license holders (holders of drug marketing license certificates), and have the right to Entrust other pharmaceutical manufacturers to produce drugs, and bear the main legal res- ponsibility for the quality of the drugs produced and sold.
Current Regulations and Guidelines for MAH Third Party Audit Service
Drug Administration Law
Administrative Measures for Drug Registration