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Summary of MHRA GCP StEM

On 18-Jul-2023, Jamie Toth (HSRAA Chair) attended the MHRA GCP StEM in Canary Wharf, London.  Karen Roy, CDISC TMF Reference Model Chair, also was in attendance along with 40 other representatives across industry and various sectors impacted by the ICH E6 (R3) changes. 

The group in attendance had the opportunity to provide direct commentary, line by line for the various sections, with the most dialog during the Data Governance and Annex C Essential Records sections.  Hearing how the MHRA worked alongside the other members of ICH to formulate the guidance was very helpful, as well as their overall rationale that GCP principles should be a thoughtful, deliberative, and risk-based process.  

While the public consultation continues until end of August for MHRA (early September for FDA), the various rapporteurs then need to get back together to review all feedback, so final guidance may not be released until sometime in 2024.