Public Consultation on ICH Guidelines M11 “Clinical electronic Structured Harmonized Protocol (CeSHarP)” and Q5A(R2) “Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin”

28 November 2022 – Swissmedic launched the public consultation on ICH guidelines M11 and Q5A(R2), with a deadline for comments of 26 February 2023 and 10 February 2023, respectively.

Stakeholders are invited to comment on ICH Guideline M11 “Clinical electronic Structured Harmonized Protocol (CeSHarP)” andICH Guideline Q5A(R2) “Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin” until 26 February and 10 February 2023, respectively.

ICH Guideline M11 ICH Guideline Q5A(R2) 
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