Regulatory Focus™ > News Articles > MHRA Consolidates Clinical Practice Guidelines, Regulations in New Guide

MHRA Consolidates Clinical Practice Guidelines, Regulations in New Guide

Posted 24 September 2012 | By Alexander Gaffney, RAC 

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has released a new guide on Good Clinical Practices (GCPs) for regulatory professionals, calling it the "authoritative guide" for understanding the legislative and regulatory framework surrounding GCPs.

MHRA's Good Clinical Practice Guide, released 24 September 2012, is the result of UK regulators receiving frequent feedback that its GCP framework was too disparate and was in need of a single document to be used for reference purposes, it said in a statement.

"It is intended that this guide will complement currently available legislation and guidance and provide practical advice about implementing the principles of Good Clinical Practice (GCP) across the wide range of trials conducted in the UK, within the context of the clinical trial regulatory framework in the European Union," MHRA wrote.

The 14-chapter guide covers a wide range of subjects, including sponsor oversight, interpreting data, monitoring and oversight,  documentation and adverse event monitoring.

Similar guides already exist in the UK for Good Pharmacovigilance Practices, Good Laboratory Practices, and Good Distribution Practices.

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