AstraZeneca Pty Ltd — China registrations and re-registration filing lines
7 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest filing line: 2027-04-24.
| Approval number | Product | Certificate expires | Filing line (Art. 82) |
|---|---|---|---|
| 国药准字HJ20181231 | LOSEC MUPS 奥美拉唑镁肠溶片 | 2027-10-24 | 2027-04-24 |
| 国药准字HJ20181232 | LOSEC MUPS 奥美拉唑镁肠溶片 | 2027-10-24 | 2027-04-24 |
| 国药准字HJ20181233 | LOSEC MUPS 奥美拉唑镁肠溶片 | 2027-10-24 | 2027-04-24 |
| 国药准字HJ20181234 | LOSEC MUPS 奥美拉唑镁肠溶片 | 2027-10-24 | 2027-04-24 |
| 国药准字HJ20140474 | Pulmicort Respules 吸入用布地奈德混悬液 | 2028-11-29 | 2028-05-29 |
| 国药准字HJ20140475 | Pulmicort Respules 吸入用布地奈德混悬液 | 2028-11-29 | 2028-05-29 |
| 国药准字HJ20240118 | Acalabrutinib Maleate Tablets 马来酸阿可替尼片 | 2029-10-28 | 2029-04-28 |
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.