SinoReg

GlaxoSmithKline Trading Services Limited — China drug registrations and re-registration deadlines

8 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2027-07-03.

Approval numberProductCertificate expiresRe-registration deadline (Art. 82)
国药准字HJ20180005ANORO
乌美溴铵维兰特罗吸入粉雾剂
2028-01-032027-07-03
国药准字HJ20180044Fluticasone Furoate and Vilanterol Trifenatate Powder for Inhalation (Ⅱ)
糠酸氟替卡松维兰特罗吸入粉雾剂(Ⅱ)
2028-06-062027-12-06
国药准字HJ20180045Fluticasone Furoate and Vilanterol Trifenatate Powder for Inhalation (Ⅲ)
糠酸氟替卡松维兰特罗吸入粉雾剂(Ⅲ)
2028-06-062027-12-06
国药准字HJ20160515Avodart
度他雄胺软胶囊
2029-05-122028-11-12
国药准字SJ20260023EXDENSUR
德莫奇单抗注射液
2031-03-242030-09-24
国药准字SJ20260024EXDENSUR
德莫奇单抗注射液
2031-03-242030-09-24
国药准字SJ20260029BLENREP
注射用玛贝兰妥单抗
2031-04-132030-10-13
国药准字SJ20260030BLENREP
注射用玛贝兰妥单抗
2031-04-132030-10-13

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.

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