Clinical Research and GCP Update

Latest news from MHRA STEM 15 March 2021

• ICH E6 currently undergoing extensive review (R3) • Estimated ready for endorsement/public consultation by Dec 2021 and full adoption November 2022. • Will include major revisions to − data governance, − monitoring − more on proportionality, − emphasis on reliability of trial results, rather than the accuracy of every single data point, − involvement of subjects in trial design and electronic systems. • (2 Members of MHRA are on ICH EWG as representatives of PIC/S Pharmaceutical Inspection Co ‐ operation Scheme)

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When might E8 R1 & E6 R3 be completed (Step 4)?

• E8 R1 - ICH Workplan (23 Sep 2020) - Step 4 planned for Feb 2021 (?) - Sometime 2021? • E6 R3 - ICH Workplan (09 Sep 2020) – R3 Core and Annex I - Nov 2022. MHRA STEM (March 2021):- E6 R3 Consultation Dec 2021, Step 4 by Nov 2022

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© Brookwood Global (Canary Ltd) 2021

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