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Combination products face new UK regulatory structure:

This article was originally published in Clinica

Executive Summary

Drug/device combination products in the UK will be subject to the regulations of a new Commission on Human Medicines (CHM) from October 30 2005, when it replaces the Medicines Commission and the Committee on Safety of Medicines (CSM). The move, set out in regulations announced last week, responds to a growing need for scientific specialisation in the committee structure, said the Medicines and Healthcare products Regulatory Agency (MHRA). The most significant development is the removal of industry representation and an increased lay membership, while Expert Advisory Groups will be established to advise the CHM on product safety and other specific issues.

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