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On 27 September 2020, and following on from the amended Drug Administration Law, which came into effect on 1 December 2019, China’s National Medical Products Administration (NMPA) published the new Guidance on Quality Agreements for Contract Manufacturing Arrangements of Drugs in China (the Guidance). The Guidance includes a template quality agreement and also sets forth the regulatory aspects of contract drug manufacturing that the NMPA will focus on in its audits and inspections.

Authors: Amy Yin

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.