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Europe considers setting up borderline product committee while CMC to help decision-making

This article was originally published in Clinica

Executive Summary

The European Commission is considering setting up a “supra directives committee” to help those in the sector determine the correct regulatory pathway for borderline products. So said Graeme Tunbridge, head of Medical Devices EU Business at the UK Medicines and Healthcare products Regulatory Agency, when speaking at Association of British Healthcare Industries’ annual regulatory meeting on 15 December in London.

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