Boehringer Ingelheim Pharma GmbH & Co. KG — 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 number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20130498 | Atrovent 异丙托溴铵吸入气雾剂 | 2028-01-03 | 2027-07-03 |
| 国药准字HJ20130499 | Atrovent 异丙托溴铵吸入气雾剂 | 2028-01-03 | 2027-07-03 |
| 国药准字HJ20150468 | Mucosolvan 盐酸氨溴索注射液 | 2028-06-27 | 2027-12-27 |
| 国药准字HJ20150469 | Mucosolvan 盐酸氨溴索注射液 | 2028-06-27 | 2027-12-27 |
| 国药准字HJ20150158 | Atrovent 吸入用异丙托溴铵溶液 | 2029-09-28 | 2029-03-28 |
| 国药准字HJ20150159 | Atrovent 吸入用异丙托溴铵溶液 | 2029-09-28 | 2029-03-28 |
| 国药准字SJ20160054 | Actilyse 注射用阿替普酶 | 2031-05-07 | 2030-11-07 |
| 国药准字SJ20160055 | Actilyse 注射用阿替普酶 | 2031-05-07 | 2030-11-07 |
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.