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Guideline on quality, non-clinical and clinical ...
1 31 January 2019. 2 EMA/CAT/852602/2018. 3 Committee for Advanced Therapies (CAT). 4 Guideline on quality, non- clinical and clinical requirements 5 for investigational advanced therapy medicinal products 6 in clinical trials 7 Draft 8. Adopted by Committee for Advanced Therapies (CAT) December 2018. Adopted by Committee for Medicinal Product for Human Use (CHMP) for January 2019. release for consultation Start of public consultation 21 February 2019. End of consultation (deadline for comments) 1 August 2019. Adopted by CAT and CHMP <DD Month YYYY>. Date for coming into effect <DD Month YYYY>. 9. 10. Comments should be provided using this template. The completed comments form should be sent to 11. Keywords Investigational ATMPs, Gene therapy medicinal product, Cell therapy medicinal product, tissue engineered product, Exploratory trial, First in human trial, Confirmatory trial 30 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555.
ERA – Environmental Risk Assessment . FIH – First in Human . GCP – Good Clinical Practice . GMP – Good Manufacturing Practice. GMO – genetically modified organism . GTIMP – Gene Therapy Investigational Medicinal Product . ICH - International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
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