ARTICLE SUMMARY:
The concept of a globally harmonized emergency use pathway, particularly for diagnostics, was proposed during a recent online gathering of global device regulators and industry regulatory affairs professionals. Excerpted from Pathways’ Picks, March 17.
“I would ask the IMDRF to consider development of a common emergency use pathway that can be leveraged globally should we ever end up in an emergency situation like this again,” said Danelle Miller, VP of Global Regulatory Policy & Intelligence at Roche Diagnostics, during a March 16 virtual workshop convened by the International Medical Device Regulators Forum and DITTA, the global imaging trade association. Such a pathway, Miller said, “would certain bring clarity to the regulatory paradigms, as well as support regulators who can have these in place before we get to this point again.”
The workshop brought together device regulators from IMDRF member countries and industry representatives to discuss regulatory takeaways from COVID-19. Many of the participants emphasized the importance of regulatory flexibility, close engagement by regulators with industry and patients, and steady attention to supply chain weakness in the past year’s emergency response. Miller also presented a handy table summarizing different countries’ pandemic regulatory responses, in terms of authorization timelines and reliance on shared international regulatory processes:
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