— guideline on human cell-based medicinal products (EMEA/CHMP/410869/2006) |
— guideline on the non-clinical studies required before first clinical use of gene therapy medicinal products (EMEA/CHMP/GTWP/125459/2006) |
— guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells (EMA/CAT/GTWP/671639/2008) |
— guideline on the risk-based approach according to annex I, part IV of Directive 2001/83/EC applied to advanced therapy medicinal products (EMA/CAT/CPWP/686637/2011) |
— guideline on safety and efficacy follow-up—risk management of advanced therapy medicinal products [EMEA/149995/2008] |
— guideline on scientific requirements for the environmental risk assessment of gene therapy medicinal products [EMEA/CHMP/GTWP/125491/2006] |
— detailed guidelines on good clinical practice specific to advanced therapy medicinal products [ENTR/F/2/SF/dn D(2009) 35810] |
— reflection paper on stem cell-based medicinal products [EMA/CAT/571134/2009] |
— reflection paper on classification of advanced therapy medicinal products [EMA/CAT/600280/2010] |
— draft reflection paper on clinical aspects related to tissue engineered products [EMA/CAT/CPWP/573420/2009] |
— reflection paper on management of clinical risks deriving from insertional mutagenesis [EMA/CAT/190186/2012] |
— European Directorate for the Quality of Medicines—guide to the quality and safety of tissues and cells for human application 1st edition |
— Ph. Eur. Monograph 5.2.12 on raw materials for the production of cell-based and gene therapy products [Pharmeuropa—Issue 26.4, 2014] |
— annex 2 of Directive 2003/94/EC: manufacture of biological medicinal products for human use |
— guideline on potency testing of cell-based immunotherapy medicinal products for the treatment of cancer (CHMP/BWP/271475/06) |
— guideline on development and manufacture of lentiviral vectors (CPMP/BWP/2458/03) |
— EMA Scientific Guideline: quality, pre-clinical and clinical aspects of gene transfer medicinal products (CHMP/GTWP/234523/09) |
— EMA Scientific Guideline: gene therapy product quality aspects in the production of vectors and genetically modified somatic cells (3AB6A) |