Amgen Europe B.V. — China drug registrations and re-registration deadlines
4 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2027-11-05.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20230046 | Parsabiv 盐酸依特卡肽注射液 | 2028-05-05 | 2027-11-05 |
| 国药准字HJ20230047 | Parsabiv 盐酸依特卡肽注射液 | 2028-05-05 | 2027-11-05 |
| 国药准字HJ20230048 | Parsabiv 盐酸依特卡肽注射液 | 2028-05-05 | 2027-11-05 |
| 国药准字SJ20200019 | Prolia 地舒单抗注射液 | 2030-02-06 | 2029-08-06 |
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.