Snapshot

The COVID-19 Technology Access Pool (C-TAP) pathway has been developed by the World Health Organization (WHO) of WHO.

This pathway can be used where In May 2020, WHO and partners launched the COVID-19 Technology Access Pool (C-TAP) to facilitate timely, equitable and affordable access of COVID-19 health products. C-TAP provides a global one-stop shop for developers of COVID-19 therapeutics, diagnostics, vaccines and other health products to voluntarily share their intellectual property, knowledge, and data, with quality-assured manufacturers through public health-driven and transparent licenses. Pooling COVID-19 health technologies or products can promote innovation or further development and facilitate scale up production through multiple manufacturers that currently have untapped capacity to scale up and diversify production. C-TAP’s priority in the last two years has been engagement with technology holders to encourage sharing of intellectual property, know-how or data to promote global equitable access of COVID-19 vaccines, therapeutics, diagnostics or other medical devices. While recent licenses indicate the potential of the mechanism to promote access and innovation, significant challenges remain in realizing the full potential of C-TAP. .

This pathway accelerates the regulatory review process.

COVID 19 candidate technologies/products are included into C-TAP technology transfer pool following a technical assessment of the relevant information and data made available to C-TAP. Candidate technologies from all C-TAP streams (IVDs, vaccines, medical devices and medicines) are categorized into 5 C-TAP Categories on the basis of provided evidence of product/technology’s potential to meet the clinical/performance/intended use/label claims, as applicable, i.e. the evidence of already meeting, or the potential to meet the relevant applicable regulatory requirements. The quality of evidence largely depends on the stage of development and manufacture of candidate technology/finished therapeutic good i.e. whether the candidate technology is at the proof of concept stage, or at a prototype manufacturing stage with some performance data/clinical evidence available, or at the fully developed and manufactured product stage with either an Emergency Use or full regulatory approval from a national/international regulatory authority or WHO.