The National Medical Products Administration has introduced a series of measures aimed at accelerating the marketing authorisation process in China for overseas-approved drugs addressing significant unmet clinical needs, including treatments for rare diseases.
Key measures include expedited review and approval pathways, broader acceptance of overseas clinical data and international multicentre trials, reduced registration testing timelines, risk-based overseas inspections (including remote verification), and streamlined temporary import procedures for rare disease therapies.
The measures further demonstrate China’s commitment to improving patient access through more efficient regulatory pathways, while creating new opportunities for pharmaceutical companies navigating China drug registration requirements and developing effective rare disease compliance and market entry strategies.