Novartis Europharm Limited — China drug registrations and re-registration deadlines
20 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2026-12-08.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20181024 | Travatan 曲伏前列素滴眼液 | 2027-06-08 | 2026-12-08 |
| 国药准字HJ20181043 | Exelon 重酒石酸卡巴拉汀胶囊 | 2027-07-28 | 2027-01-28 |
| 国药准字HJ20181044 | Exelon 重酒石酸卡巴拉汀胶囊 | 2027-07-28 | 2027-01-28 |
| 国药准字SJ20220016 | Xolair 奥马珠单抗注射液 | 2027-08-29 | 2027-02-28 |
| 国药准字SJ20265001 | Xolair 奥马珠单抗注射液 | 2027-08-29 | 2027-02-28 |
| 国药准字SJ20265002 | Xolair 奥马珠单抗注射液 | 2027-08-29 | 2027-02-28 |
| 国药准字HJ20170379 | Exelon 利斯的明透皮贴剂 | 2027-09-04 | 2027-03-04 |
| 国药准字HJ20170380 | Exelon 利斯的明透皮贴剂 | 2027-09-04 | 2027-03-04 |
| 国药准字HJ20180025 | Zykadia 塞瑞替尼胶囊 | 2027-11-15 | 2027-05-15 |
| 国药准字HJ20181123 | DuoTrav 曲伏噻吗滴眼液 | 2028-06-06 | 2027-12-06 |
| 国药准字HJ20230103 | Inclisiran Sodium Injection 英克司兰钠注射液 | 2028-08-21 | 2028-02-21 |
| 国药准字SJ20230014 | Aimovig 依瑞奈尤单抗注射液 | 2028-09-18 | 2028-03-18 |
| 国药准字HJ20190040 | Brinzolamide and Brimonidine Eye Drops 布林佐胺溴莫尼定滴眼液 | 2029-01-15 | 2028-07-15 |
| 国药准字HJ20140976 | Azopt 布林佐胺滴眼液 | 2029-01-30 | 2028-07-30 |
| 国药准字HJ20181122 | Brinzolamide and Timolol Maleate Eye Drops 布林佐胺噻吗洛尔滴眼液 | 2029-02-27 | 2028-08-27 |
| 国药准字HJ20181146 | Patanol 盐酸奥洛他定滴眼液 | 2029-04-08 | 2028-10-08 |
| 国药准字HJ20190066 | Tafinlar 甲磺酸达拉非尼胶囊 | 2029-09-09 | 2029-03-09 |
| 国药准字HJ20190067 | Tafinlar 甲磺酸达拉非尼胶囊 | 2029-09-09 | 2029-03-09 |
| 国药准字HJ20190068 | Mekinist 曲美替尼片 | 2029-09-09 | 2029-03-09 |
| 国药准字HJ20190069 | Mekinist 曲美替尼片 | 2029-09-09 | 2029-03-09 |
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.