Compassionate / Expanded Access
This page provides a plain English reference for compassionate / expanded access under China's NMPA regulatory framework. Full content to be completed during editorial review.
Regulatory basis
Special access and designation pathways are established under NMPA orders and announcements. See What's New for the latest updates to these programmes.
Content on this site is written with AI assistance and is intended as a navigation aid only. Always verify against official NMPA sources before making regulatory decisions. Not affiliated with NMPA or any Chinese Government body. Not legal or regulatory advice.
Add a complete section under 'Regulatory basis' explaining: (1) that China does not have a formal 'compassionate use' or 'expanded access' programme equivalent to FDA or EU frameworks; (2) that humanitarian access may be possible under emergency use or special circumstances but requires direct negotiation with NMPA; (3) reference relevant NMPA orders/announcements if any exist for named patient access; (4) note that this is typically handled on a case-by-case basis with no standardized pathway.