Information and interesting ideas

Topics posted here will be in the realm of bioanalysis and biomarkers as part of new therapeutic development, with the occasional post of scientific topics that I find interesting.

Tuesday, May 2, 2023

MHRA Blog on ICH E6(R3) Good Clinical Practice guidance - Step 2 Public Consultation

Post-BREXIT, the UKs MHRA joined ICH as an independent body in May 2022.  This notification on the Agency's Blog provides an overview of the ICH plans for revision to the existing E6(R2) Good Clinical Practice Guidance.  It notes the MHRA's intent to "consult directly with UK stakeholders to compile and co-ordinate their comments to the EWG".

 Plans are in development for "a MHRA GCP Stakeholder Engagement Meeting ... to be held concerning this document during the consultation period"; providing a second pathway for comments to be provided to the Agency.

 

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