China Drug Administration Law (2019) and expedited pathways

China, statute and administrative regulation. The revised Drug Administration Law was adopted by the Standing Committee of the National People's Congress on 26 August 2019 and took effect on 1 December 2019, the first comprehensive revision since 2001. The Drug Registration Regulation (State Administration for Market Regulation Order No. 27) followed on 1 July 2020. Primary text: the NMPA's English site publishes translations and notices.

What they changed: the law established the marketing authorisation holder system, separating the right to market a drug from the right to manufacture it; codified conditional approval for drugs treating serious, life-threatening diseases with no effective therapy, and priority review for urgently needed medicines, including paediatric and rare-disease drugs; and hardened penalties after the 2018 vaccine scandals. The registration regulation created four expedited programmes, breakthrough therapy, conditional approval, priority review (with a 130 working-day review instead of 200) and special approval for public health emergencies, and it built on the 2017 State Council reform opinions and China's 2017 accession to the International Council for Harmonisation, which allowed acceptance of overseas clinical data and ended the requirement to repeat trials in China.

Why it matters and the arguments: domestic PD-1 antibodies, BTK inhibitors and ADCs reached Chinese patients on conditional approvals based on single-arm trials, foreign cancer drugs arrived years faster, and the country became the second-largest source of new oncology candidates. Critics point to conditional approvals whose confirmatory trials lag, to a review capacity still stretched, and to the tension between speed and the 2021 guidance demanding patient-centred trial design; the National Reimbursement Drug List negotiations now determine whether approved drugs are actually affordable.