Aspen Pharmacare Australia Pty Ltd — 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: 2027-11-09.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20171317 | Alkeran 美法仑片 | 2028-05-09 | 2027-11-09 |
| 国药准字HJ20170291 | Leukeran 苯丁酸氮芥片 | 2028-10-09 | 2028-04-09 |
| 国药准字HJ20100154 | EMLA 利丙双卡因乳膏 | 2029-09-08 | 2029-03-08 |
| 国药准字HJ20140763 | Naropin 盐酸罗哌卡因注射液 | 2029-12-30 | 2029-06-30 |
| 国药准字HJ20140764 | Naropin 盐酸罗哌卡因注射液 | 2029-12-30 | 2029-06-30 |
| 国药准字HJ20140766 | Naropin 盐酸罗哌卡因注射液 | 2029-12-30 | 2029-06-30 |
| 国药准字HJ20170005 | Ovestin 雌三醇乳膏 | 2030-04-08 | 2029-10-08 |
| 国药准字HJ20170290 | Myleran 白消安片 | 2030-06-02 | 2029-12-02 |
| 国药准字HJ20170288 | Imuran 硫唑嘌呤片 | 2030-07-03 | 2030-01-03 |
| 国药准字HJ20181158 | Nimbex 苯磺顺阿曲库铵注射液 | 2031-05-05 | 2030-11-05 |
| 国药准字HJ20181159 | Nimbex 苯磺顺阿曲库铵注射液 | 2031-05-05 | 2030-11-05 |
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.