| Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products |
EMA/CAT/80183/2014 |
2015 |
| Management of clinical risks deriving from insertional mutagenesis |
CAT/190186/2012 |
2013 |
| Risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to Advanced Therapy Medicinal Products |
CAT/CPWP/686637/2011 |
2013 |
| Design modifications of gene therapy medicinal products during development |
CAT/GTWP/44236/2009 |
2012 |
| Quality, nonclinical and clinical aspects of medicinal products containing genetically modified cells |
CHMP/GTWP/671639/2008 |
2012 |
| CHMP/CAT position statement on Creutzfeldt-Jakob disease and advanced therapy medicinal products |
CHMP/CAT/BWP/353632/2010 |
2011 |
| Quality, non-clinical and clinical issues relating specifically to recombinant adeno-associated viral vectors |
CHMP/GTWP/587488/07 |
2010 |
| Questions and answers on gene therapy |
CHMP/GTWP/212377/08 |
2009 |
| ICH Considerations General Principles to Address Virus and Vector Shedding |
CHMP/ICH/449035/09 |
2009 |
| ICH Considerations - Oncolytic Viruses |
CHMP/GTWP/607698/08 |
2009 |
| Follow-up of patients administered with gene therapy medicinal products |
CHMP/GTWP/60436/07 |
2009 |
| Non-clinical studies required before first clinical use of gene therapy medicinal products |
CHMP/GTWP/125459/06 |
2008 |
| Scientific Requirements for the Environmental Risk Assessment of Gene Therapy Medicinal Products |
CHMP/GTWP/125491/06 |
2008 |
| Guideline On Safety and Efficacy Follow-Up - Risk Management of Advanced Therapy Medicinal Products |
EMEA/149995/2008
|
2008 |
| Non-Clinical testing for Inadvertent Germline transmission of Gene Transfer Vectors |
EMEA/273974/05 |
2006 |
| Development and Manufacture of Lentiviral Vectors |
CHMP/BWP/2458/03 |
2005 |
| Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal Products (superseded by EMA/CAT/80183/2014) |
CPMP/BWP/3088/99 |
2001 |
