Further information

Below you can find a compilation of documents relevant for translational research:

➚ Guidelines for Stem Cell Research and Clinical Translation, International Society for Stem Cell Research (ISSCR)
➚ Advice for drug development (e.g. regarding regulatory requirements) at the Paul-Ehrlich-Institut
➚ Decision tree ATMP classification
➚ Medicinal Products Act (translation of Arzneimittelgesetz – AMG)
➚ Guidelines on Human Cell-based Medicinal Products, European Medicines Agency (EMA)
➚ Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products, EMA