Are global policy endorsements required? If so, what kind of evidence is necessary for global policy endorsements and scale-up?


  1. 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?
  2. 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?
  3. 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?
  4. 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?


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