What Would An EU ‘Regulatory Sandbox’ Bring To New Drug Development?
Digital health, AI, real-world evidence and “proactive learning” are key components of the EU’s proposals for new ways of regulating novel medicines, but only time will tell which products might benefit from the flexibilities offered by the “regulatory sandbox.”
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From rapidly identifying antigenic targets to automating clinical trials, AI has an important role to play in cutting vaccine development time down to 100 days, says Melanie Saville, executive director of R&D at CEPI.
Proposals for the overhaul of the EU pharmaceutical legislation will make medicines more widely available, accessible and affordable while supporting innovation and boosting the “competitiveness and attractiveness” of Europe’s pharma industry, the European Commission claims. The research-based industry thinks otherwise, saying cuts in regulatory protections will undermine R&D.
The European Commission’s vision for a more agile and streamlined drug development and assessment framework includes the use of controlled regulatory environments for testing innovative new drugs and technologies.