Phase of development of health products
The standards for the classification of the phase of development of health products are not yet available. In the Monitoring section of the Observatory, the following categorization of the phase of development is used for the analysis.
- Phase 0 (= clinical / Phase 0)
- Phase I (= clinical / Phase I)
- Phase II (= clinical / Phase I/II or Clinical / Phase II)
- Phase III (= clinical / Phase II/III or Clinical / Phase III)
- Preregistration/Phase IV (=preregistration of clinical trials/ Phase IV)
- Clinical (unspecified) (=clinical phase unknown)
Diagnostics
- Development (=product development)
- Validation (=lab and clinical validation)
- Regulatory (=regulatory approvals)
- Evaluation (=WHO evaluation)
Stage of development of Vector control interventions
- Prototype development (=prototype development)
- Data generation (=Data generation to support assessment of safety, quality and entomological efficacy)
- Epidemiological trials (=Large scale epidemiology trials)
- WHO assessment (=Under assessment to inform Prequalification listing and/or WHO policy recommendation)