TGA / PMDA / NMPA · Asia-Pacific
formulation — TGA / PMDA / NMPA regulatory status
formulation 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: 135 published clinical programs and 12 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 |
|---|---|---|---|
| 0600-PG-PSC-218 | Phase 3 | Anaxis Pharma | 2025-521736-10-00 |
| 060018-PG-PSC-217 | Phase 3 | Anaxis Pharma | 2025-521709-42-00 |
| 20190529 | Phase 3 | Amgen | 2023-503435-17-00 |
| 2024/4031 | Phase 3 | George Institute for | 2024-520140-42-00 |
| 230LE301 | Phase 3 | Biogen | 2023-505634-94-00 |
| 230LE303 | Phase 3 | Biogen | 2023-505695-30-00 |
| 230LE304 | Phase 3 | Biogen | 2023-505696-74-00 |
| 230LE306 | Phase 3 | Biogen | 2023-505635-13-00 |
| DM199-2021-001 | Phase 3 | DiaMedica Therapeutics | 2024-513911-28-00 |
| GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations) | Phase 3 | GSK Glaxo Smith | NCT01051661 |
| INCA033890-303 | Phase 3 | Incyte | 2025-523735-19-00 |
| INCB 18424-326 | Phase 3 | Incyte | 2023-505433-27-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 2026106858 | FORMULATIONS ET PROCÉDÉS POUR MAINTENIR UNE SUSPENSION ET UNE VIABILITÉ DE CELLULES | WO |
| 2026087531 | FORMULATIONS DE CLASCOTÉRONE ET LEURS MÉTHODES D'UTILISATION | WO |
| 20260108463 | NANOEMULSION FORMULATION WITH IMPROVED TACROLIMUS STABILITY AND SKIN PENETRATION | US |
| 20260027049 | AVACOPAN FORMULATIONS | US |
| 2026008525 | FORMULATIONS STABLES CONTENANT DES RADIONUCLÉIDES | WO |
| 2026010917 | FORMULATIONS NUTRITIONNELLES PERMETTANT DE MAINTENIR DES MICROBIOTE ET FONCTION INTESTINAUX SAINS | WO |
| 2025242584 | FORMULATION DE CAPSULE DE GÉLATINE MOLLE STABLE POUR ÉLINZANÉTANT | WO |
| 2025242583 | NOUVELLE FORMULATION COMPRENANT DE L'ÉLINZANÉTANT DANS UNE DISPERSION SOLIDE | WO |
| 12419958 | Clinical formulations | US |
| 2025186043 | FORMULATION PHARMACEUTIQUE POUR ANTICORPS ANTI-CCR8 | WO |
| 12403183 | Factor VIII polypeptide formulations | US |
| 12403164 | Lentiviral vector formulations | US |
Related hubs
FAQ
What is the TGA / PMDA / NMPA approval status of formulation?
formulation 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 formulation 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 formulation?
This spoke lists 135 published programs associated with formulation in our pipeline index.