Merck Sharp & Dohme B.V. — China drug registrations and re-registration deadlines
28 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2026-11-09.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20220047 | Letermovir Injection 来特莫韦注射液 | 2027-05-09 | 2026-11-09 |
| 国药准字HJ20220048 | Letermovir Injection 来特莫韦注射液 | 2027-05-09 | 2026-11-09 |
| 国药准字HJ20171218 | Cancidas 注射用醋酸卡泊芬净 | 2027-07-28 | 2027-01-28 |
| 国药准字HJ20171219 | Cancidas 注射用醋酸卡泊芬净 | 2027-07-28 | 2027-01-28 |
| 国药准字HJ20181175 | BRIDION 舒更葡糖钠注射液 | 2027-10-13 | 2027-04-13 |
| 国药准字HJ20181176 | BRIDION 舒更葡糖钠注射液 | 2027-10-13 | 2027-04-13 |
| 国药准字HJ20180017 | ZEPATIER 艾尔巴韦格拉瑞韦片 | 2027-11-15 | 2027-05-15 |
| 国药准字HJ20181110 | Noxafil 泊沙康唑口服混悬液 | 2027-11-17 | 2027-05-17 |
| 国药准字HJ20140153 | JANUVIA 磷酸西格列汀片 | 2028-05-04 | 2027-11-04 |
| 国药准字HJ20180086 | Posaconazole Enteric-coated Tablets 泊沙康唑肠溶片 | 2028-07-02 | 2028-01-02 |
| 国药准字HJ20140847 | Esmeron 罗库溴铵注射液 | 2028-08-23 | 2028-02-23 |
| 国药准字HJ20171172 | ISENTRESS 拉替拉韦钾片 | 2029-01-07 | 2028-07-07 |
| 国药准字HJ20150377 | EMEND 阿瑞匹坦胶囊 | 2029-03-19 | 2028-09-19 |
| 国药准字HJ20150378 | EMEND 阿瑞匹坦胶囊 | 2029-03-19 | 2028-09-19 |
| 国药准字HJ20150379 | EMEND 阿瑞匹坦胶囊 | 2029-03-19 | 2028-09-19 |
| 国药准字HJ20150380 | EMEND 阿瑞匹坦胶囊 | 2029-03-19 | 2028-09-19 |
| 国药准字HJ20150381 | EMEND 阿瑞匹坦胶囊 | 2029-03-19 | 2028-09-19 |
| 国药准字HJ20150480 | INVANZ 注射用厄他培南钠 | 2029-11-28 | 2029-05-28 |
| 国药准字HJ20150481 | INVANZ 注射用厄他培南钠 | 2029-11-28 | 2029-05-28 |
| 国药准字HJ20240140 | RECARBRIO 注射用亚胺西瑞 | 2029-11-30 | 2029-05-30 |
| 国药准字HJ20200023 | STEGLATRO 艾托格列净片 | 2030-01-25 | 2029-07-25 |
| 国药准字HJ20250016 | Ceftolozane Sulfate and Tazobactam Sodium for Injection 注射用头孢洛生他唑巴坦钠 | 2030-02-07 | 2029-08-07 |
| 国药准字HJ20210008 | Posaconazole Injection 泊沙康唑注射液 | 2030-06-22 | 2029-12-22 |
| 国药准字HJ20200050 | PIFELTRO 多拉韦林片 | 2030-07-20 | 2030-01-20 |
| 国药准字HJ20200066 | Doravirine lamivudine and tenofovir disoproxil fumarate Tablets 多拉米替片 | 2030-07-20 | 2030-01-20 |
| 国药准字HJ20250107 | Letermovir Tablets（Ⅱ） 来特莫韦片（Ⅱ） | 2030-09-01 | 2030-03-01 |
| 国药准字HJ20250108 | Letermovir Tablets（Ⅱ） 来特莫韦片（Ⅱ） | 2030-09-01 | 2030-03-01 |
| 国药准字SJ20260038 | ENFLONSIA 克莱罗韦单抗注射液 | 2031-06-09 | 2030-12-09 |
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.