While the general principles of GCP set out in ICH Guidelines are applicable to clinical trials with ATMPs, in some cases, it may be necessary to adapt those to the specific characteristics of ATMPs (e.g. regarding retention of samples). The implementation of additional measures may also be necessary (e.g. traceability requirements for ATMPs that contain cells or tissues of human origin, follow-up of patients after end of the clinical trial, training on upstream intervention of subjects and/or administration procedures).
Clinical trials with ATMPs performed in the EU are governed by Regulation (EU) No 536/2014 on clinical trials and should comply with the requirements provided for therein, including regarding the content of the application dossier.
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