China re-registration filing lines for overseas-manufactured drugs

2510 certificates held by 553 overseas marketing authorisation holders, from the NMPA 境外生产药品库, snapshot 2026-06-28. One page per approval number, with the statutory filing line computed from the published expiry date.

The arithmetic

Under the Provisions for Drug Registration (药品注册管理办法, 2020) Art. 82, an application to renew an overseas-manufactured drug registration is filed with the Center for Drug Evaluation no later than 6 months before the certificate expires. Art. 84(1): a certificate with no application by expiry is not re-registered and is cancelled at expiry. So the date that matters operationally is not the expiry printed on the certificate — it is 6 months earlier.

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Every figure is taken from the public NMPA overseas-manufactured drug database as of 2026-06-28, or computed from it under Art. 82. Certificates whose filing line has already passed are not listed, and Hong Kong / Macau / Taiwan (C) certificates are excluded because Art. 82 does not name their accepting authority. Registration data changes; the NMPA portal governs. These pages state no view on any holder's Domestic Responsible Person (境内责任人) arrangement under NMPA Announcement No. 137 — that cannot be determined from a public entry.