Merck Sharp & Dohme LLC — China drug registrations and re-registration deadlines
11 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2026-10-06.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字SJ20170037 | GARDASIL 四价人乳头瘤病毒疫苗（酿酒酵母） | 2027-04-06 | 2026-10-06 |
| 国药准字SJ20170038 | GARDASIL 四价人乳头瘤病毒疫苗（酿酒酵母） | 2027-04-06 | 2026-10-06 |
| 国药准字HJ20181007 | Tienam 注射用亚胺培南西司他丁钠 | 2027-08-04 | 2027-02-04 |
| 国药准字HJ20181008 | Tienam 注射用亚胺培南西司他丁钠 | 2027-08-04 | 2027-02-04 |
| 国药准字SJ20180002 | ROTATEQ 口服五价重配轮状病毒减毒活疫苗(Vero细胞) | 2028-03-19 | 2027-09-19 |
| 国药准字SJ20180008 | GARDASIL 9 九价人乳头瘤病毒疫苗（酿酒酵母） | 2028-03-30 | 2027-09-30 |
| 国药准字SJ20215001 | GARDASIL 9 九价人乳头瘤病毒疫苗（酿酒酵母） | 2028-03-30 | 2027-09-30 |
| 国药准字SJ20140114 | Pneumovax 23价肺炎球菌多糖疫苗 | 2030-05-05 | 2029-11-05 |
| 国药准字SJ20181013 | Pneumovax 23价肺炎球菌多糖疫苗 | 2030-05-05 | 2029-11-05 |
| 国药准字SJ20250032 | WINREVAIR 注射用索特西普 | 2030-12-29 | 2030-06-29 |
| 国药准字SJ20250033 | WINREVAIR 注射用索特西普 | 2030-12-29 | 2030-06-29 |
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.