Roche Pharma（Schweiz）AG — China drug registrations and re-registration deadlines
7 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2026-10-21.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字SJ20170035 | Avastin 贝伐珠单抗注射液 | 2027-04-21 | 2026-10-21 |
| 国药准字SJ20230019 | Phesgo 帕妥珠曲妥珠单抗注射液（皮下注射） | 2028-12-25 | 2028-06-25 |
| 国药准字SJ20230020 | Phesgo 帕妥珠曲妥珠单抗注射液（皮下注射） | 2028-12-25 | 2028-06-25 |
| 国药准字SJ20160029 | MabThera 利妥昔单抗注射液 | 2031-02-04 | 2030-08-04 |
| 国药准字SJ20160030 | MabThera 利妥昔单抗注射液 | 2031-02-04 | 2030-08-04 |
| 国药准字SJ20160031 | MabThera 利妥昔单抗注射液 | 2031-02-04 | 2030-08-04 |
| 国药准字SJ20170002 | MabThera 利妥昔单抗注射液 | 2031-02-04 | 2030-08-04 |
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.