Dr. Falk Pharma GmbH — China drug registrations and re-registration deadlines
7 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2029-01-04.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20140948 | Salofalk 美沙拉秦栓 | 2029-07-04 | 2029-01-04 |
| 国药准字HJ20150127 | Salofalk 美沙拉秦灌肠液 | 2029-07-04 | 2029-01-04 |
| 国药准字HJ20150280 | Salofalk 美沙拉秦栓 | 2029-07-04 | 2029-01-04 |
| 国药准字HJ20240072 | Ursodeoxycholic Acid Oral Suspension 熊去氧胆酸口服混悬液 | 2029-07-15 | 2029-01-15 |
| 国药准字HJ20171358 | Salofalk 美沙拉秦肠溶片 | 2029-09-09 | 2029-03-09 |
| 国药准字HJ20181059 | Ursofalk 熊去氧胆酸胶囊 | 2029-10-10 | 2029-04-10 |
| 国药准字HJ20202002 | Salofalk 美沙拉秦肠溶片 | 2029-12-10 | 2029-06-10 |
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.