Committee for Non-Clinical Safety Evaluation of Pluripotent Stem Cell-derived Product
Activity Report

Management policy

  • Through the “AMED MEASURE” activities, consider safety evaluation methods which harmonize with international regulatory policy and which is important for research and development of pluripotent stem cell-derived product in order to gain a consensus globally.
  • Validate Tumorigenicity tests and Pharmacokinetic Studies through conducting multi-site studies.

 

(*Multisite Evaluation Study on Analytical Methods for Non-clinical Safety Assessment of human-derived Regenerative Medical Products)

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