The use of regulatory “sandboxes” to test out new approaches to the development and assessment of novel medicines could become widespread in the EU if proposals for the overhaul of the pharmaceutical legislation are approved.
‘Regulatory Sandbox’ In EU's Sights For Innovative Drug Development & Approval
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.
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The chair of a European Medicines Agency working group on reducing animal testing said that companies can provide “thoughts and suggestions” in relation to a review of its scientific guidelines on regulatory testing requirements and new approach methodologies.
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
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