Pfizer Australia Pty Ltd — China drug registrations and re-registration deadlines
13 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2026-12-15.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20220054 | Isavuconazonium Sulfate for Injection 注射用硫酸艾沙康唑 | 2027-06-15 | 2026-12-15 |
| 国药准字HJ20140205 | Methotrexate Injection 甲氨蝶呤注射液 | 2028-07-27 | 2028-01-27 |
| 国药准字HJ20140206 | Methotrexate Injection 甲氨蝶呤注射液 | 2028-07-27 | 2028-01-27 |
| 国药准字HJ20140207 | Methotrexate Injection 甲氨蝶呤注射液 | 2028-07-27 | 2028-01-27 |
| 国药准字HJ20150350 | Anzatax 紫杉醇注射液 | 2029-11-03 | 2029-05-03 |
| 国药准字HJ20150351 | Anzatax 紫杉醇注射液 | 2029-11-03 | 2029-05-03 |
| 国药准字HJ20090596 | ———— 甲氨蝶呤注射液 | 2029-11-06 | 2029-05-06 |
| 国药准字HJ20090597 | ———— 甲氨蝶呤注射液 | 2029-11-06 | 2029-05-06 |
| 国药准字HJ20245005 | ———— 甲氨蝶呤注射液 | 2030-05-18 | 2029-11-18 |
| 国药准字HJ20160576 | CAMPTO 盐酸伊立替康注射液 | 2030-12-09 | 2030-06-09 |
| 国药准字HJ20160577 | CAMPTO 盐酸伊立替康注射液 | 2030-12-09 | 2030-06-09 |
| 国药准字HJ20160578 | CAMPTO 盐酸伊立替康注射液 | 2030-12-09 | 2030-06-09 |
| 国药准字HJ20260017 | Isavuconazonium Sulfate Capsules 硫酸艾沙康唑胶囊 | 2031-01-26 | 2030-07-26 |
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.