What Would An EU ‘Regulatory Sandbox’ Bring To New Drug Development?

Commentary appearing in a Covington blog post about navigating the European Commission’s “regulatory sandbox” was included in a Pink Sheet article detailing how the regulatory framework affects testing innovative medicines and other medical technologies.

“It is difficult to predict what innovations might benefit from a regulatory sandbox – they are by definition technologies that will be considered innovative after the legislation is adopted in a few years’ time,” stated Covington's blog post on the subject.

“The only certainty is that the sandbox would only be available for products that may be regulated as medicinal products. However, the proposal envisages sandboxes being used to assess services and approaches, and makes specific reference to deployment in the context of ‘digitization,’ which clearly envisages a role for digital health and AI.”

According to Covington, while much of the detail regarding the regulatory sandbox and eligibility for it has yet to be clarified, “its potential for innovative medicines and associated methods and services is exciting, particularly because it may result in faster market access, perhaps using adaptive licensing procedures and greater reliance on real world evidence.”

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