Roche Registration GmbH — China drug registrations and re-registration deadlines
3 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2026-10-07.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字SJ20220013 | Tocilizumab Injection (Subcutaneous Injection) 托珠单抗注射液（皮下注射） | 2027-04-07 | 2026-10-07 |
| 国药准字HJ20180047 | Alecensa 盐酸阿来替尼胶囊 | 2028-07-23 | 2028-01-23 |
| 国药准字SJ20200004 | Tecentriq 阿替利珠单抗注射液 | 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.