AstraZeneca UK Limited — China drug registrations and re-registration deadlines
26 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HJ20181003 | Nexium 艾司奥美拉唑镁肠溶片 | 2027-11-15 | 2027-05-15 |
| 国药准字HJ20181004 | Nexium 艾司奥美拉唑镁肠溶片 | 2027-11-15 | 2027-05-15 |
| 国药准字HJ20181005 | Nexium 艾司奥美拉唑镁肠溶片 | 2027-11-15 | 2027-05-15 |
| 国药准字HJ20181006 | Nexium 艾司奥美拉唑镁肠溶片 | 2027-11-15 | 2027-05-15 |
| 国药准字HJ20181035 | Casodex 比卡鲁胺片 | 2027-11-17 | 2027-05-17 |
| 国药准字HJ20181036 | Casodex 比卡鲁胺片 | 2027-11-17 | 2027-05-17 |
| 国药准字HJ20230044 | KOSELUGO 硫酸氢司美替尼胶囊 | 2028-04-27 | 2027-10-27 |
| 国药准字HJ20230045 | KOSELUGO 硫酸氢司美替尼胶囊 | 2028-04-27 | 2027-10-27 |
| 国药准字HJ20140719 | Casodex 比卡鲁胺片 | 2028-11-29 | 2028-05-29 |
| 国药准字HJ20140720 | Casodex 比卡鲁胺片 | 2028-11-29 | 2028-05-29 |
| 国药准字HJ20140691 | Arimidex 阿那曲唑片 | 2028-12-03 | 2028-06-03 |
| 国药准字HJ20140692 | Arimidex 阿那曲唑片 | 2028-12-03 | 2028-06-03 |
| 国药准字SJ20190038 | IMFINZI 度伐利尤单抗注射液 | 2029-05-22 | 2028-11-22 |
| 国药准字SJ20190039 | IMFINZI 度伐利尤单抗注射液 | 2029-05-22 | 2028-11-22 |
| 国药准字HJ20250046 | TRUQAP 卡匹色替片 | 2030-04-14 | 2029-10-14 |
| 国药准字HJ20250047 | TRUQAP 卡匹色替片 | 2030-04-14 | 2029-10-14 |
| 国药准字HJ20160244 | ZOLADEX 醋酸戈舍瑞林缓释植入剂 | 2030-08-21 | 2030-02-21 |
| 国药准字HJ20160245 | ZOLADEX 醋酸戈舍瑞林缓释植入剂 | 2030-08-21 | 2030-02-21 |
| 国药准字HJ20160259 | ZOLADEX 醋酸戈舍瑞林缓释植入剂 | 2030-08-21 | 2030-02-21 |
| 国药准字HJ20160260 | ZOLADEX 醋酸戈舍瑞林缓释植入剂 | 2030-08-21 | 2030-02-21 |
| 国药准字HJ20160545 | Crestor 瑞舒伐他汀钙片 | 2031-01-03 | 2030-07-03 |
| 国药准字HJ20160546 | Crestor 瑞舒伐他汀钙片 | 2031-01-03 | 2030-07-03 |
| 国药准字HJ20160547 | Crestor 瑞舒伐他汀钙片 | 2031-01-03 | 2030-07-03 |
| 国药准字HJ20160548 | Crestor 瑞舒伐他汀钙片 | 2031-01-03 | 2030-07-03 |
| 国药准字HJ20160611 | Crestor 瑞舒伐他汀钙片 | 2031-01-03 | 2030-07-03 |
| 国药准字HJ20160612 | Crestor 瑞舒伐他汀钙片 | 2031-01-03 | 2030-07-03 |
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.