TGA / PMDA / NMPA · Asia-Pacific
infusion — TGA / PMDA / NMPA regulatory status
infusion regulatory status in the Asia-Pacific is tracked from public TGA / PMDA / NMPA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: NMPA clinical trials.
Status snapshot
- Status
- NMPA clinical trials
- Structured fields
- 4
Regional decision snapshot — NMPA: clinical trials.
Linked evidence on this spoke: 1046 published clinical programs and 6 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| NMPA | China | clinical trials | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| 000434 | Phase 3 | Ferring Pharmaceuticals | 2024-512177-27-01 |
| 042011 | Phase 3 | George Institute for | 2024-512676-36-00 |
| 1001 | Phase 3 | Biotest Farmaceutica Ltda | 2024-513002-60-00 |
| 1438-0011 | Phase 3 | Boehringer Ingelheim | 2025-523869-22-00 |
| 1438-0012 | Phase 3 | Boehringer Ingelheim | 2025-520565-51-00 |
| 1479-0008 | Phase 3 | Boehringer Ingelheim | 2023-504308-27-00 |
| 1479-0032 | Phase 3 | Boehringer Ingelheim | 2025-521284-12-00 |
| 17000139BLC3001 | Phase 3 | Janssen-Cilag International N.V | 2023-507188-21-00 |
| 19356A | Phase 3 | H. Lundbeck A/S | 2024-510656-13-00 |
| 2019/2894 | Phase 3 | George Institute for | 2024-514917-36-00 |
| 20190172 | Phase 3 | Amgen | 2024-511187-81-00 |
| 2022-009 | Phase 3 | Ningbo Cancer Hospital | 2024-516576-15-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 11904052 | Methods for ameliorating infusion reactions | US |
| 11351118 | Methods for ameliorating infusion reactions | US |
| 10736975 | Infusion administration of conjugated monoclonal antibodies | US |
| 10632255 | Drug infusion device | US |
| 9480669 | Method of destroying and preventing bacterial and fungal biofilm by amino acid infusion | US |
| 102004006048 | Pharmazeutische Kombination aus Gadolinium Komplexen und kolloidalen Biopolymeren und deren Verwendung als kontrastverstärkendes Mittel zur i.v. Injektion bzw. i.v. Infusion in der MR Angiographie | DE |
Related hubs
FAQ
What is the TGA / PMDA / NMPA approval status of infusion?
infusion currently shows NMPA clinical trials in our Asia-Pacific regulatory index. Confirm on the official TGA / PMDA / NMPA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get infusion regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to infusion?
This spoke lists 1046 published programs associated with infusion in our pipeline index.