Welsh Government

European Medicines Agency are undertaking a consultation

27 November 2015

The European Medicines Agency are undertaking a consultation on an addendum to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E6 (R2) guideline on good clinical practice (GCP). This Addendum is proposed to modernise ICH E6 to enable implementation of innovative approaches to clinical trial design, management, oversight, conduct, documentation, and reporting that will better ensure human subject protection and data quality. A copy of the consultation document is linked above.

The HRA is coordinating a UK-wide response to the attached consultation. Please send any comments on the document by 15 January 2016 to clive.collett@nhs.net at the HRA and copy to DSCHR@wales.gsi.gov.uk.

Please note any comments should be confined to the added text in the document clearly identified by the heading “ADDENDUM” and marked by vertical lines each side of the text.