Search the website

Search results

98 results

Sort by

List item

Draft guideline on process validation - Revision 1 (PDF/123.75 KB)

Draft guideline on process validation - Revision … Draft guideline on process validation - Revision … Guideline on Process Validation …

Draft: consultation closed
First published: 13/04/2012
Last updated: 13/04/2012
Consultations dates: from 15/03/2012 to 31/10/2012
EMA/CHMP/CVMP/QWP/70278/2012-Rev1
List item

Draft guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products (PDF/548.89 KB)

Draft guideline on the quality, non-clinical … Draft guideline on the quality, non-clinical … Draft guideline on the quality, non-clinical …

Draft: consultation closed
First published: 20/05/2015
Last updated: 20/05/2015
Consultations dates: from 20/05/2015 to 31/08/2015
EMA/CAT/80183/2014
List item

Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products (PDF/427.63 KB)

Guideline on the quality, non-clinical … Guideline on the quality, non-clinical … Guideline on the quality, non-clinical …

Adopted
First published: 13/07/2018
Last updated: 13/07/2018
EMA/CAT/80183/2014
List item

Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells - Revision 1 (PDF/523.18 KB)

Guideline on quality, non-clinical … Document details Guideline on quality, non-clinical … Advanced Therapies (CAT) Guideline on quality, non-clinical …

Adopted
First published: 17/12/2020
Legal effective date: 01/06/2021
EMA/CAT/GTWP/671639/2008 Rev. 1
List item

Guideline on the minimum quality and non-clinical data for certification of advanced therapy medicinal products (PDF/132.52 KB)

Guideline on the minimum quality and … Guideline on the minimum quality and … Scientific guideline on minimum quality and nocn-clinical …

Adopted
First published: 19/06/2009
Last updated: 10/11/2010
EMEA/CAT/486831/2008/corr.
List item

CAT monthly report of application procedures, guidelines and related documents on advanced therapies: December 2014 meeting (PDF/143.31 KB)

of application procedures, guidelines and related documents on … of application procedures, guidelines and related documents on … of application procedures, guidelines and related documents on …

First published: 06/01/2015
Last updated: 06/01/2015
EMA/CAT/789277/2014
List item

CAT monthly report of application procedures, guidelines and related documents on advanced therapies: July 2014 meeting (PDF/141.58 KB)

of application procedures, guidelines and related documents on … of application procedures, guidelines and related documents on … on application procedures, guidelines and related documents on …

First published: 30/07/2014
Last updated: 30/07/2014
EMA/CAT/434851/2014
List item

Overview of comments received on draft scientific guideline on the minimum quality and non-clinical data for certification of advanced therapy medicinal products (PDF/130.19 KB)

received on draft scientific guideline on the minimum quality and … received on draft scientific guideline on the minimum quality and … of comments on Scientific guideline on minimum quality and nocn-clinical …

First published: 10/11/2010
Last updated: 10/11/2010
EMA/CAT/45852/2010
List item

Guideline on the risk-based approach according to annex I, part IV of Directive 2001/83/EC applied to advanced-therapy medicinal products (PDF/197.79 KB)

Guideline on the risk-based approach … Guideline on the risk-based approach … Guideline on the risk-based approach …

Adopted
First published: 08/03/2013
Last updated: 08/03/2013
Legal effective date: 12/02/2013
EMA/CAT/CPWP/686637/2011
List item

Draft guideline on the risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to advanced-therapy medicinal products (PDF/281.13 KB)

Draft guideline on the risk-based approach … Draft guideline on the risk-based approach … Draft Guideline on the risk-based approach …

Draft: consultation closed
First published: 24/01/2012
Last updated: 24/01/2012
Consultations dates: from 19/01/2012 to 30/06/2012
EMA/CAT/CPWP/686637/2011
List item

Overview of comments received on 'Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells - Revision 1' (PDF/1.59 MB)

comments received on 'Draft guideline on quality, non-clinical … comments received on 'Draft guideline on quality, non-clinical … the revision of the ‘Guideline on quality, non-clinical …

First published: 17/12/2020
EMA/34765/2019
List item

Committee for Advanced Therapies (CAT): 8-9 September 2016

European Medicines Agency, London, UK, from 08/09/2016 to 09/09/2016, Last updated: 09/09/2016

of application procedures, guidelines and related documents on …
List item

Committee for Advanced Therapies (CAT): 10-11 December 2015

European Medicines Agency, London, UK, from 10/12/2015 to 11/12/2015, Last updated: 02/09/2014

of application procedures, guidelines and related documents on …
List item

Committee for Advanced Therapies (CAT): 15-16 October 2015

European Medicines Agency, London, UK, from 15/10/2015 to 16/10/2015, Last updated: 02/09/2014

of application procedures, guidelines and related documents on …
List item

Committee for Advanced Therapies (CAT): 17-18 September 2015

European Medicines Agency, London, UK, from 17/09/2015 to 18/09/2015, Last updated: 02/09/2014

of application procedures, guidelines and related documents on … of applicatin procedures, guidelines and related documents on … of application procedures, guidelines and related documents on …
List item

Committee for Advanced Therapies (CAT): 3-4 November 2016

European Medicines Agency, London, UK, from 03/11/2016 to 04/11/2016, Last updated: 06/01/2015

of application procedures, guidelines and related documents on …
List item

Committee for Advanced Therapies (CAT): 12-13 May 2015

European Medicines Agency, London, UK, from 12/05/2015 to 13/05/2015, Last updated: 02/09/2014

of application procedures, guidelines and related documents on …
List item

Committee for Advanced Therapies (CAT): 6-8 September 2017

European Medicines Agency, London, UK, from 06/09/2017 to 08/09/2017, Last updated: 06/01/2015

of application procedures, guidelines and related documents on …
List item

Committee for Advanced Therapies (CAT): 18-19 February 2016

European Medicines Agency, London, UK, from 18/02/2016 to 19/02/2016, Last updated: 06/01/2015

of application procedures, guidelines and related documents on …
List item

Committee for Advanced Therapies (CAT): 17-18 July 2014

European Medicines Agency, London, UK, from 17/07/2014 to 18/07/2014, Last updated: 09/08/2013

of application procedures, guidelines and related documents on … hMIP-1α via a dimerization module derived from human IgG3 …
List item

Committee for Advanced Therapies (CAT): 21-22 January 2016

European Medicines Agency, London, UK, from 21/01/2016 to 22/01/2016, Last updated: 06/01/2015

of application procedures, guidelines and related documents on …
List item

Committee for Advanced Therapies (CAT): 15-16 May 2014

European Medicines Agency, London, UK, from 15/05/2014 to 16/05/2014, Last updated: 09/08/2013

of application procedures, guidelines and related documents on …
List item

Committee for Advanced Therapies (CAT): 15-16 April 2014

European Medicines Agency, London, UK, from 15/04/2014 to 16/04/2014, Last updated: 09/08/2013

of application procedures, guidelines and related documents on …
List item

Committee for Advanced Therapies (CAT): 18-19 September 2014

European Medicines Agency, London, UK, from 18/09/2014 to 19/09/2014, Last updated: 09/08/2013

of application procedures, guidelines and related documents on … list of questions related to module 3 and module 5. The feasibility analysis …
List item

Committee for Advanced Therapies (CAT): 11-12 December 2014

European Medicines Agency, London, UK, from 11/12/2014 to 12/12/2014, Last updated: 09/08/2014

of application procedures, guidelines and related documents on …

98 results

Draft guideline on process validation - Revision 1 (PDF/123.75 KB)

Draft guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products (PDF/548.89 KB)

Guideline on the quality, non-clinical and clinical aspects of gene therapy medicinal products (PDF/427.63 KB)

Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells - Revision 1 (PDF/523.18 KB)

Guideline on the minimum quality and non-clinical data for certification of advanced therapy medicinal products (PDF/132.52 KB)

CAT monthly report of application procedures, guidelines and related documents on advanced therapies: December 2014 meeting (PDF/143.31 KB)

CAT monthly report of application procedures, guidelines and related documents on advanced therapies: July 2014 meeting (PDF/141.58 KB)

Overview of comments received on draft scientific guideline on the minimum quality and non-clinical data for certification of advanced therapy medicinal products (PDF/130.19 KB)

Guideline on the risk-based approach according to annex I, part IV of Directive 2001/83/EC applied to advanced-therapy medicinal products (PDF/197.79 KB)

Draft guideline on the risk-based approach according to Annex I, part IV of Directive 2001/83/EC applied to advanced-therapy medicinal products (PDF/281.13 KB)

Overview of comments received on 'Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells - Revision 1' (PDF/1.59 MB)

Committee for Advanced Therapies (CAT): 8-9 September 2016

Committee for Advanced Therapies (CAT): 10-11 December 2015

Committee for Advanced Therapies (CAT): 15-16 October 2015

Committee for Advanced Therapies (CAT): 17-18 September 2015

Committee for Advanced Therapies (CAT): 3-4 November 2016

Committee for Advanced Therapies (CAT): 12-13 May 2015

Committee for Advanced Therapies (CAT): 6-8 September 2017

Committee for Advanced Therapies (CAT): 18-19 February 2016

Committee for Advanced Therapies (CAT): 17-18 July 2014

Committee for Advanced Therapies (CAT): 21-22 January 2016

Committee for Advanced Therapies (CAT): 15-16 May 2014

Committee for Advanced Therapies (CAT): 15-16 April 2014

Committee for Advanced Therapies (CAT): 18-19 September 2014

Committee for Advanced Therapies (CAT): 11-12 December 2014