GUERBET — China drug registrations and re-registration deadlines
11 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2027-05-15.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20171362 | Iodinated Oil Injection 碘化油注射液 | 2027-11-15 | 2027-05-15 |
| 国药准字HJ20150567 | Optiray 碘佛醇注射液 | 2030-06-08 | 2029-12-08 |
| 国药准字HJ20150568 | Optiray 碘佛醇注射液 | 2030-06-08 | 2029-12-08 |
| 国药准字HJ20150571 | Optiray 碘佛醇注射液 | 2030-06-08 | 2029-12-08 |
| 国药准字HJ20150572 | Optiray 碘佛醇注射液 | 2030-06-08 | 2029-12-08 |
| 国药准字HJ20160125 | DOTAREM 钆特酸葡胺注射液 | 2030-12-04 | 2030-06-04 |
| 国药准字HJ20160126 | DOTAREM 钆特酸葡胺注射液 | 2030-12-04 | 2030-06-04 |
| 国药准字HJ20160128 | DOTAREM 钆特酸葡胺注射液 | 2030-12-04 | 2030-06-04 |
| 国药准字HJ20160374 | Xenetix 碘比醇注射液 | 2031-03-26 | 2030-09-26 |
| 国药准字HJ20160376 | Xenetix 碘比醇注射液 | 2031-03-26 | 2030-09-26 |
| 国药准字HJ20160377 | Xenetix 碘比醇注射液 | 2031-03-26 | 2030-09-26 |
Under the Provisions for Drug Registration (药品注册管理办法) 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; the filing line column is that arithmetic applied to the expiry cell. Art. 84(1): a certificate with no application by expiry is not re-registered and is cancelled at expiry. Every figure is taken from the public NMPA database as of 2026-06-28, or computed from it. Registration data changes; the NMPA portal governs. This page states no view on whether any of these products' Domestic Responsible Person (境内责任人) arrangements meet NMPA Announcement No. 137 — that cannot be determined from a public entry.