Roche Molecular Systems, Inc. — China drug registrations and re-registration deadlines
2 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2026-10-26.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字SJ20220014 | cobas MPX 乙型肝炎病毒 丙型肝炎病毒 人类免疫缺陷病毒(1+2型)核酸检测试剂盒（PCR-荧光法） | 2027-04-26 | 2026-10-26 |
| 国药准字SJ20181014 | cobas TaqScreen MPX Test, version 2.0 乙型肝炎病毒丙型肝炎病毒人类免疫缺陷病毒(1+2型)核酸检测试剂盒(PCR-荧光法) | 2027-12-29 | 2027-06-29 |
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.