CHEPLAPHARM Arzneimittel GmbH — 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: 2026-12-12.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20171188 | Xenical 奥利司他胶囊 | 2027-06-12 | 2026-12-12 |
| 国药准字HJ20171189 | Xenical 奥利司他胶囊 | 2027-06-12 | 2026-12-12 |
| 国药准字HJ20160224 | Gemzar 注射用盐酸吉西他滨 | 2027-12-27 | 2027-06-27 |
| 国药准字HJ20160225 | Gemzar 注射用盐酸吉西他滨 | 2027-12-27 | 2027-06-27 |
| 国药准字HJ20130464 | Etalpha 阿法骨化醇滴剂 | 2028-07-10 | 2028-01-10 |
| 国药准字HJ20130513 | Etalpha 阿法骨化醇软胶囊 | 2028-07-12 | 2028-01-12 |
| 国药准字HJ20130374 | Cymevene 注射用更昔洛韦 | 2028-10-09 | 2028-04-09 |
| 国药准字HJ20140591 | Dormicum 马来酸咪达唑仑片 | 2029-06-16 | 2028-12-16 |
| 国药准字HJ20150330 | Valcyte 盐酸缬更昔洛韦片 | 2029-09-02 | 2029-03-02 |
| 国药准字HJ20171227 | Taxol 紫杉醇注射液 | 2030-11-25 | 2030-05-25 |
| 国药准字HJ20260029 | Vitamin K₁ Injection 维生素K₁注射液 | 2031-03-24 | 2030-09-24 |
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.