Merck Europe B.V. — China drug registrations and re-registration deadlines
6 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2027-04-09.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字SJ20171039 | Erbitux 西妥昔单抗注射液 | 2027-10-09 | 2027-04-09 |
| 国药准字SJ20181004 | Luveris 注射用重组人促黄体激素α | 2027-10-09 | 2027-04-09 |
| 国药准字SJ20181005 | Luveris 注射用重组人促黄体激素α | 2027-10-09 | 2027-04-09 |
| 国药准字SJ20181008 | GONAL-f 注射用重组人促卵泡激素 | 2028-01-15 | 2027-07-15 |
| 国药准字SJ20130091 | Ovidrel 重组人绒促性素注射液 | 2028-08-01 | 2028-02-01 |
| 国药准字SJ20260012 | Human Follitropin alfa and Lutropin alfa for Injection 注射用人促卵泡激素α促黄体激素α | 2031-02-01 | 2030-08-01 |
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.