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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
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Draft guideline on the use of adjuvanted veterinary vaccines (PDF/181.05 KB)

Draft guideline on the use of adjuvanted … Draft guideline on the use of adjuvanted … Guideline on requirements for adjuvants …

Draft: consultation closed
First published: 05/07/2018
Last updated: 05/07/2018
Consultations dates: from 05/07/2018 to 15/01/2019
EMA/CVMP/IWP/315887/2017
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Draft guideline on the chemistry of active substances (veterinary) (PDF/208.64 KB)

Draft guideline on the chemistry of active … Draft guideline on the chemistry of active … Draft guideline on the chemistry of active …

Draft: consultation closed
First published: 13/02/2017
Last updated: 13/02/2017
Consultations dates: from 13/02/2017 to 13/08/2017
EMA/CVMP/QWP/49477/2017
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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
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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
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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
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Guideline on the chemistry of active substances for veterinary medicinal products (PDF/202.65 KB)

Guideline on the chemistry of active … Guideline on the chemistry of active … Guideline on the chemistry of active …

Adopted
First published: 19/01/2018
Last updated: 19/01/2018
EMA/CVMP/QWP/707366/2017
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Draft guideline on regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches (PDF/256.58 KB)

Draft guideline on regulatory acceptance … Draft guideline on regulatory acceptance … Veterinary Use (CVMP) 4 Guideline on regulatory acceptance …

Draft: consultation closed
First published: 03/10/2014
Last updated: 03/10/2014
Consultations dates: from 03/10/2014 to 31/12/2014
EMA/CHMP/CVMP/JEG-3Rs/450091/2012
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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.
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Draft guideline on assessment and control of DNA reactive, mutagenic impurities in veterinary medicines (PDF/268.91 KB)

Draft guideline on assessment and control … Draft guideline on assessment and control … Guideline on assessment and control …

Draft: consultation closed
First published: 24/02/2017
Last updated: 24/02/2017
Consultations dates: from 24/02/2017 to 31/08/2017
EMA/CVMP/SWP/377245/2016
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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
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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
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Guideline on dossier requirements for anticancer medicinal products for dogs and cats (PDF/224.61 KB)

Guideline on dossier requirements for … Document details Guideline on dossier requirements for … VETERINARY USE (CVMP) GUIDELINE ON DOSSIER REQUIREMENTS FOR …

Adopted
First published: 20/04/2009
Last updated: 20/04/2009
Legal effective date: 01/11/2009
EMEA/CVMP/28510/2008
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Draft guideline on dossier requirements for anticancer medicinal products for dogs and cats (consultation) (PDF/198.82 KB)

Draft guideline on dossier requirements for … Draft guideline on dossier requirements for … Guideline on dossier requirements for …

Draft: consultation closed
First published: 21/01/2008
Last updated: 21/01/2008
MEA/CVMP/28510/2008-CONSULTATION
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Guideline on harmonising the approach to causality assessment for adverse reactions to veterinary medicinal products (PDF/217.87 KB)

Guideline on harmonising the approach … Guideline on harmonising the approach … Guideline on harmonising the Approach …

Adopted
First published: 15/04/2004
Last updated: 15/04/2004
Legal effective date: 15/10/2004
EMEA/CVMP/552/03
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
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News: Reducing off-label use of antimicrobials in veterinary medicine to reduce risk of resistance

CVMP, Last updated: 25/07/2017

development of related treatment guidelines, and stimulate the development … facilitated by use 66 of treatment guidelines that have already considered … bodies preparing treatment guidelines. 69 4. The development by …
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 …

294 results

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

Draft guideline on the use of adjuvanted veterinary vaccines (PDF/181.05 KB)

Draft guideline on the chemistry of active substances (veterinary) (PDF/208.64 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 chemistry of active substances for veterinary medicinal products (PDF/202.65 KB)

Draft guideline on regulatory acceptance of 3R (replacement, reduction, refinement) testing approaches (PDF/256.58 KB)

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

Draft guideline on assessment and control of DNA reactive, mutagenic impurities in veterinary medicines (PDF/268.91 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)

Guideline on dossier requirements for anticancer medicinal products for dogs and cats (PDF/224.61 KB)

Draft guideline on dossier requirements for anticancer medicinal products for dogs and cats (consultation) (PDF/198.82 KB)

Guideline on harmonising the approach to causality assessment for adverse reactions to veterinary medicinal products (PDF/217.87 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)

News: Reducing off-label use of antimicrobials in veterinary medicine to reduce risk of resistance

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