Domestic Agent (MAH)Management System
Since the introduction of the MAH system in China, we have conducted in-depth research and analysis of MAH related regulations and have established a full management system to meet the MAH requirements, including but not limited to
- Having a quality management system appropriate to the work performed as an agent and a quality management system appropriate to its responsibilities
- Having office space, means of communication, and contact telephone numbers that are appropriate for performing agency work
- Having a management system that can ensure product traceability
- Have an in-depth understanding of the annual reporting system in China and have helped several pharmaceutical companies to provide annual reports to CDE
- Have the management system and capability of post-marketing recall, quality complaint handling, quality compensation, etc. of drugs
- Have a pharmacovigilance system to carry out monitoring, identification, assessment and control of post-marketing adverse drug reactions and other harmful reactions related to drug use