Takeda Pharmaceuticals International AG Ireland Branch — China drug registrations and re-registration deadlines
6 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2028-08-19.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字SJ20240008 | Revestive 注射用替度格鲁肽 | 2029-02-19 | 2028-08-19 |
| 国药准字SJ20200021 | REPLAGAL 阿加糖酶α注射用浓溶液 | 2030-05-18 | 2029-11-18 |
| 国药准字HJ20171351 | Fosrenol 碳酸镧咀嚼片 | 2030-11-27 | 2030-05-27 |
| 国药准字HJ20171352 | Fosrenol 碳酸镧咀嚼片 | 2030-11-27 | 2030-05-27 |
| 国药准字SJ20210013 | VPRIV 注射用维拉苷酶α | 2031-02-08 | 2030-08-08 |
| 国药准字HJ20210024 | Icatibant Acetate Injection 醋酸艾替班特注射液 | 2031-05-06 | 2030-11-06 |
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.