Are global policy endorsements required? If so, what kind of evidence is necessary for global policy endorsements and scale-up?
- What global policy endorsements or approvals are critical for success (e.g. WHO, CDC, FDA, others)? What level of interaction and evidence is required for these endorsements?
- Is WHO endorsement/policy the most important factor for accessing global markets? If not, what is? Historically, what is the timeline for these endorsements/policies? What will it cost to collect evidence for such approvals and policies? How does WHO decide on which technologies to consider for policy review?
- Is there a WHO prequalification process for TB diagnostics, and if so, how long will the process take? What is the difference between WHO policy and WHO prequalification for TB?
- What kind of evidence is required at the country level to get policy endorsements and registration? Is WHO endorsement or prequalification alone sufficient for country-level policy adoption and registration? Are country evaluations still required?