BIOCODEX — China registrations and re-registration filing lines
7 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest filing line: 2029-11-13.
| Approval number | Product | Certificate expires | Filing line (Art. 82) |
|---|---|---|---|
| 国药准字SJ20150051 | Bioflor 250mg sachets 布拉氏酵母菌散 | 2030-05-13 | 2029-11-13 |
| 国药准字SJ20150052 | Bioflor 250mg Capsules 布拉氏酵母菌胶囊 | 2030-05-27 | 2029-11-27 |
| 国药准字ZJ20110014 | 递法明片 | 2031-02-01 | 2030-08-01 |
| 国药准字ZJ20110015 | 递法明片 | 2031-02-01 | 2030-08-01 |
| 国药准字ZJ20150004 | 递法明片 | 2031-02-01 | 2030-08-01 |
| 国药准字HJ20260042 | Stiripentol Capsules 司替戊醇胶囊 | 2031-04-13 | 2030-10-13 |
| 国药准字HJ20260043 | Stiripentol Capsules 司替戊醇胶囊 | 2031-04-13 | 2030-10-13 |
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.