Novartis Pharma NV — China drug registrations and re-registration deadlines
5 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2027-10-24.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20150119 | TobraDex 妥布霉素地塞米松滴眼液 | 2028-04-24 | 2027-10-24 |
| 国药准字HJ20181124 | Betoptic S 盐酸倍他洛尔滴眼液 | 2028-06-15 | 2027-12-15 |
| 国药准字HJ20140811 | Tobrex 妥布霉素滴眼液 | 2029-01-15 | 2028-07-15 |
| 国药准字HJ20181125 | Tobrex 妥布霉素眼膏 | 2030-06-30 | 2029-12-30 |
| 国药准字HJ20181126 | TobraDex 妥布霉素地塞米松眼膏 | 2030-07-03 | 2030-01-03 |
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.