SinoReg

Pharmacosmos A/S — 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: 2026-11-22.

Approval numberProductCertificate expiresRe-registration deadline (Art. 82)
国药准字HJ20170106CosmoFer
右旋糖酐铁注射液
2027-05-222026-11-22
国药准字HJ20170107CosmoFer
右旋糖酐铁注射液
2027-05-222026-11-22
国药准字HJ20220066Trilaciclib Hydrochloride for Injection
注射用盐酸曲拉西利
2027-07-112027-01-11
国药准字HJ20210005Iron Isomaltoside Injection
异麦芽糖酐铁注射液
2030-12-162030-06-16
国药准字HJ20210006Iron Isomaltoside Injection
异麦芽糖酐铁注射液
2030-12-162030-06-16
国药准字HJ20210007Iron Isomaltoside Injection
异麦芽糖酐铁注射液
2030-12-162030-06-16

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.

All holders  ·  China re-registration deadline index