DiaSorin Italia S.p.A. UK Branch — 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: 2028-02-24.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字SJ20140044 | ICE* Syphilis 梅毒螺旋体抗体诊断试剂盒(酶联免疫法) | 2028-08-24 | 2028-02-24 |
| 国药准字SJ20150002 | Diagnostic Kit for Antibody and Antigen to Human Immunodeficiency Virus (Elisa) 人类免疫缺陷病毒抗体抗原联合诊断试剂盒（酶联免疫法） | 2029-01-14 | 2028-07-14 |
| 国药准字SJ20200009 | Diagnostic Kit for Antibody to Hepatitis C Virus (Elisa) 丙型肝炎病毒抗体检测试剂盒(酶联免疫法) | 2029-10-07 | 2029-04-07 |
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.