The Cell and Gene Therapy Discussion Group (CGTDG) began working in 2023 and has just release a recommended roadmap for ICH to develop harmonized regulations for advanced therapy medicinal products (ATMPs). In the introductory paragraphs, the CGTDG notes:
"At this time, the absence of international guidance on many considerations during the life cycle of an ATMP and the lack of harmonisation for ATMP regulatory expectations result in challenges to global drug development and regulatory decision making. The rapid evolution of new technologies in the ATMP field also makes it challenging to establish regulatory expectations, particularly given the emerging new types of ATMP products and manufacturing processes.
Within the document, it goes on to provide a table that lays out "the CGTDG's recommendations for specific key topics and how to address them within the ICH framework in the future.". The table includes recommendations on prioritization.
It will be interesting to see what Working Groups are proposed and then implemented in 2026 in response to these recommendations.
https://database.ich.org/sites/default/files/ICH_CGTDG_RecommendationPaper_2025_1201_MCEndorsed_2025_1117.pdf
#ICH #ATMP #RegulatoryRoadmap
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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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