ISEV
maintains the MISEV guidelines (most recently updated as MISEV2023), which set the field's minimal characterization standards for confirming vesicle identity, purity and membrane-marker profile — standards both EMA and FDA reference when evaluating EV-based product submissions.
- Country
- Belgium
standards-body
eu
Coverage
| CN | EU | US | |
|---|---|---|---|
| regenerative-personalized | ✓ | ✓ | ✓ |
Regulatorsfdaemanmpa
Technologies
| Name | Cluster | Risk | |
|---|---|---|---|
| Exosome therapy & extracellular vesicles | regenerative-personalized | High | → |
Compiled by BIOECON via the bioecon-brief pipeline.
Compliance
Bioecon is an information intermediary; it is not a regulator, a certification body, or a legal advisor. When working with public-sector customers (procurement under 44-FZ / 223-FZ), Bioecon acts solely as an independent analytical platform, with no remuneration from suppliers.