International Medical Research Frontier

Through the introduction of MAH and CDMO both experienced early, middle and listing three stages of cooperation, and began in safety, quality audit, and research and development capabilities and production capacity matching CDMO reached cooperation, the two sides signed the agreement on research and development, production and quality agreements, establish their improve the file management system, and implementation of product technology transfer, After the subsequent products are approved to be listed, they will be transferred to the daily system operation. The normal production and supply shall be supervised by on-site supervision, and the delivery and release of materials and products shall be carried out. It is expected to provide ideas and reference for the continuous improvement of Chinese MAH system and the exploration of long-term cooperation mode between MAH and CDMO.

Drug marketing authorization holder; Contract R&D and production organization; MAH; CDMO