This draft ICH guideline is open for consultation with a deadline of 15Sep25.
From the guideline's Objective:
"The objective of this guideline is to provide recommendations for the appropriate inclusion and/or retention of pregnant and/or breastfeeding individuals in clinical trials and facilitate the generation of robust clinical data that allow for evidence-based decision making on the safe and effective use of medicinal products by these individuals and their healthcare providers (HCPs)."
Having worked on a few of these trials, it is an interesting read to compare with those practices.
Details on the format of responses and where to send are included in the draft guideline: https://www.ema.europa.eu/en/documents/other/ich-e21-guideline-inclusion-pregnant-breastfeeding-individuals-clinical-trials_en.pdf
#ICH #E21 #EMA #pregnantwomen #breastfeeding #clinicaltrial
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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