Multidisciplinary: Gene Therapy

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TopicDocumentsReference numberPublication dateEffective dateRemarks
Management of clinical risks deriving from insertional mutagenesisReflection paperCAT/190186/2012Aug 2013  
Design modifications of gene therapy medicinal products during developmentReflection paperCAT/GTWP/44236/2009Feb 2012  
CHMP/CAT position statement on Creutzfeldt-Jakob disease and advanced therapy medicinal products

Adopted guideline

Overview of comments

Draft guideline

CHMP/CAT/BWP/353632/2010June 2011June 2011 
Quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells

Adopted guideline
Overview of comments

Draft guideline
Concept paper

CHMP/GTWP/671639/2008May 2012  
Risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to Advanced Therapy Medicinal Products

Adopted guideline

Draft guideline

Concept paper

CAT/CPWP/686637/2011Mar 2013Feb 2013 
Questions and answers on gene therapyAdopted guidelineCHMP/GTWP/212377/08Dec 2009Dec 2009 
Quality, non-clinical and clinical aspects of gene therapy medicinal products

Draft guideline

Concept paper

EMA/CAT/80183/2014Release for consultation May 2015 Deadline for comments 31 August 2015
ICH Considerations General Principles to Address Virus and Vector SheddingConcept paperCHMP/ICH/449035/09July 2009July 2009 
Quality, non-clinical and clinical issues relating specifically to recombinat adeno-associated viral vectors

Overview of comments

Adopted guideline

Concept paper

CHMP/GTWP/587488/07Release for consultation Mar 2009 Deadline for comments Sep 2009
ICH Considerations - Oncolytic Viruses

Adopted guideline

Draft guideline

CHMP/GTWP/607698/08Oct 2009  
Non-clinical studies required before first clinical use of gene therapy medicinal products

Overview of comments

Adopted guideline

Draft guideline

Concept paper

CHMP/GTWP/125459/06May 2008Nov 2008 
Follow-up of patients administered with gene therapy medicinal products

Overview of comments

Adopted guideline

Draft guideline

Concept paper

CHMP/GTWP/60436/07Nov 2009May 2010 
Scientific Requirements for the Environmental Risk Assessment of Gene Therapy Medicinal Products

Overview of comments

Adopted guideline

Draft guideline

Concept paper

CHMP/GTWP/125491/06May 2008Nov 2008 
Non-Clinical testing for Inadvertent Germline transmission of Gene Transfer Vectors

Overview of comments

Adopted guideline

Draft guideline

EMEA/273974/05Dec 2006May 2007 
Development and Manufacture of Lentiviral VectorsAdopted guidelineCHMP/BWP/2458/03May 2005Nov 2005 
Quality, Preclinical and Clinical Aspects of Gene Transfer Medicinal ProductsAdopted guidelineCPMP/BWP/3088/99Apr 2001Oct 2001 

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