SinoReg

Pfizer Europe MA EEIG — China drug registrations and re-registration deadlines

50 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2026-10-26.

Approval numberProductCertificate expiresRe-registration deadline (Art. 82)
国药准字HJ20220040LORBRENA
洛拉替尼片
2027-04-262026-10-26
国药准字HJ20220041LORBRENA
洛拉替尼片
2027-04-262026-10-26
国药准字HJ20171137SUTENT
苹果酸舒尼替尼胶囊
2027-07-282027-01-28
国药准字HJ20171138SUTENT
苹果酸舒尼替尼胶囊
2027-07-282027-01-28
国药准字HJ20171139SUTENT
苹果酸舒尼替尼胶囊
2027-07-282027-01-28
国药准字HJ20171140SUTENT
苹果酸舒尼替尼胶囊
2027-07-282027-01-28
国药准字HJ20171141SUTENT
苹果酸舒尼替尼胶囊
2027-07-282027-01-28
国药准字HJ20171142SUTENT
苹果酸舒尼替尼胶囊
2027-07-282027-01-28
国药准字HJ20171143SUTENT
苹果酸舒尼替尼胶囊
2027-07-282027-01-28
国药准字HJ20171144SUTENT
苹果酸舒尼替尼胶囊
2027-07-282027-01-28
国药准字HJ20181102Vfend
注射用伏立康唑
2027-10-242027-04-24
国药准字SJ20150003Xyntha
注射用重组人凝血因子Ⅷ
2027-11-142027-05-14
国药准字SJ20150004Xyntha
注射用重组人凝血因子Ⅷ
2027-11-142027-05-14
国药准字SJ20150005Xyntha
注射用重组人凝血因子Ⅷ
2027-11-142027-05-14
国药准字SJ20150006Xyntha
注射用重组人凝血因子Ⅷ
2027-11-142027-05-14
国药准字SJ20120053BeneFIX
注射用重组人凝血因子Ⅸ
2027-12-212027-06-21
国药准字SJ20120054BeneFIX
注射用重组人凝血因子Ⅸ
2027-12-212027-06-21
国药准字SJ20120055BeneFIX
注射用重组人凝血因子Ⅸ
2027-12-212027-06-21
国药准字SJ20120056BeneFIX
注射用重组人凝血因子Ⅸ
2027-12-212027-06-21
国药准字HJ20150129Vfend
伏立康唑干混悬剂
2028-05-282027-11-28
国药准字HJ20180040IBRANCE
哌柏西利胶囊
2028-05-282027-11-28
国药准字HJ20180041IBRANCE
哌柏西利胶囊
2028-05-282027-11-28
国药准字HJ20180042IBRANCE
哌柏西利胶囊
2028-05-282027-11-28
国药准字HJ20130697Sirolimus Tablets
西罗莫司片
2028-06-132027-12-13
国药准字HJ20130698Sirolimus Tablets
西罗莫司片
2028-06-132027-12-13
国药准字HJ20171221Champix
酒石酸伐尼克兰片
2028-08-092028-02-09
国药准字HJ20171222Champix
酒石酸伐尼克兰片
2028-08-092028-02-09
国药准字HJ20171223Champix
酒石酸伐尼克兰片
2028-08-092028-02-09
国药准字HJ20150051Vfend
伏立康唑片
2028-10-092028-04-09
国药准字HJ20150052Vfend
伏立康唑片
2028-10-092028-04-09
国药准字HJ20190036Vizimpro
达可替尼片
2029-02-272028-08-27
国药准字HJ20190037Vizimpro
达可替尼片
2029-02-272028-08-27
国药准字SJ20170048Enbrel
依那西普注射液
2029-06-052028-12-05
国药准字SJ20170049Enbrel
依那西普注射液
2029-06-052028-12-05
国药准字HJ20200001Vyndaqel
氯苯唑酸葡胺软胶囊
2029-06-272028-12-27
国药准字HJ20150219Inlyta
阿昔替尼片
2029-08-182029-02-18
国药准字HJ20150220Inlyta
阿昔替尼片
2029-08-182029-02-18
国药准字HJ20150221Inlyta
阿昔替尼片
2029-08-182029-02-18
国药准字HJ20150222Inlyta
阿昔替尼片
2029-08-182029-02-18
国药准字HJ20240122TALZENNA
甲苯磺酸他拉唑帕利胶囊
2029-10-282029-04-28
国药准字HJ20240123TALZENNA
甲苯磺酸他拉唑帕利胶囊
2029-10-282029-04-28
国药准字HJ20240124TALZENNA
甲苯磺酸他拉唑帕利胶囊
2029-10-282029-04-28
国药准字HJ20200041Vyndamax
氯苯唑酸软胶囊
2030-03-242029-09-24
国药准字HJ20250078Aztreonam and Avibactam Sodium for Injection
注射用氨曲南阿维巴坦钠
2030-06-232029-12-23
国药准字SJ20160042Prevenar 13
13价肺炎球菌多糖结合疫苗
2030-12-212030-06-21
国药准字HJ20160471Tygacil
注射用替加环素
2031-01-042030-07-04
国药准字HJ20160472Tygacil
注射用替加环素
2031-01-042030-07-04
国药准字HJ20181078Xeljanz
枸橼酸托法替布片
2031-05-052030-11-05
国药准字HJ20181079Xeljanz
枸橼酸托法替布片
2031-05-052030-11-05
国药准字HJ20181080Xeljanz
枸橼酸托法替布片
2031-05-052030-11-05

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