1. Reform of market authorisation holder system
As part of the reform initiatives to encourage R&D and facilitate the commercialisation of drug products in China, the NMPA introduced a nationwide market authorisation holder (MAH) system in the amended Drug Administration Law. Historically, only drug manufacturers that have good manufacturing practice (GMP) level manufacturing facilities and capabilities could hold the registration of drug products in China. The NMPA now allows qualified non-manufacturing entities, such as R&D institutions that develop drug products but do not have their own GMP facilities, to become the MAH by engaging a qualified contract manufacturing organisation (CMO) to produce the drugs1 under a contract manufacturing arrangement. The Drug Administration Law further provides that the MAH and CMO must, as a minimum, sign a contract manufacturing agreement and a quality agreement to govern the manufacturing activities and the NMPA shall develop related guidelines.