Recordati Rare Diseases — China drug registrations and re-registration deadlines
5 certificates in the NMPA overseas-manufactured drug database (境外生产药品库), snapshot 2026-06-28. Earliest re-registration deadline: 2027-12-26.
| Approval number | Product | Certificate expires | Re-registration deadline (Art. 82) |
|---|---|---|---|
| 国药准字HJ20230085 | Carglumic Acid Dispersible Tablets 卡谷氨酸分散片 | 2028-06-26 | 2027-12-26 |
| 国药准字HJ20240101 | ISTURISA 磷酸奥唑司他片 | 2029-09-18 | 2029-03-18 |
| 国药准字HJ20250048 | Pasireotide Pamoate Microspheres for Injection 注射用双羟萘酸帕瑞肽微球 | 2030-04-21 | 2029-10-21 |
| 国药准字HJ20250049 | Pasireotide Pamoate Microspheres for Injection 注射用双羟萘酸帕瑞肽微球 | 2030-04-21 | 2029-10-21 |
| 国药准字HJ20250050 | Pasireotide Pamoate Microspheres for Injection 注射用双羟萘酸帕瑞肽微球 | 2030-04-21 | 2029-10-21 |
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.