Gilead Sciences Ireland UC — 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: 2027-02-02.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20170365 | SOVALDI 索磷布韦片 | 2027-08-02 | 2027-02-02 |
| 国药准字HJ20180024 | Epclusa 索磷布韦维帕他韦片 | 2028-01-03 | 2027-07-03 |
| 国药准字HJ20180043 | Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide Fumarate Tablets 艾考恩丙替片 | 2028-02-13 | 2027-08-13 |
| 国药准字HJ20233123 | Amphotericin B Liposome for Injection 注射用两性霉素B脂质体 | 2028-02-13 | 2027-08-13 |
| 国药准字HJ20180068 | Harvoni 来迪派韦索磷布韦片 | 2028-06-06 | 2027-12-06 |
| 国药准字HJ20180066 | Emtricitabine and Tenofovir Alafenamide Fumarate Tablets（Ⅰ） 恩曲他滨丙酚替诺福韦片(Ⅰ) | 2028-06-18 | 2027-12-18 |
| 国药准字HJ20180060 | Tenofovir alafenamide Fumarate Tablets 富马酸丙酚替诺福韦片 | 2028-07-12 | 2028-01-12 |
| 国药准字HJ20190047 | Biktarvy 比克恩丙诺片 | 2029-04-15 | 2028-10-15 |
| 国药准字HJ20190061 | Vosevi 索磷维伏片 | 2029-11-11 | 2029-05-11 |
| 国药准字HJ20240169 | SUNLENCA 来那帕韦钠片 | 2029-12-24 | 2029-06-24 |
| 国药准字HJ20240170 | SUNLENCA 来那帕韦钠注射液 | 2029-12-24 | 2029-06-24 |
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.