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Guideline on Influenza vaccines – Quality module Revision 1 (PDF/345.62 KB)

Guideline on Influenza vaccines – … Influenza vaccines – Quality module Revision 1 … Guideline on Influenza vaccines – …

Adopted
First published: 28/07/2017
Last updated: 28/07/2017
EMA/CHMP/BWP/310834/2012 Rev. 1
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Guideline on influenza vaccines – Quality module (PDF/283.56 KB)

Guideline on influenza vaccines – … influenza vaccines – Quality module … Guideline on influenza vaccines – …

Adopted
First published: 02/06/2014
Last updated: 02/06/2014
Legal effective date: 01/11/2014
EMA/CHMP/BWP/310834/2012
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Draft guideline on influenza vaccines – quality module (PDF/277.15 KB)

Draft guideline on influenza vaccines – … influenza vaccines – quality module … Draft guideline on influenza vaccines – …

Draft: consultation closed
First published: 08/03/2013
Last updated: 08/03/2013
Consultations dates: from 08/03/2013 to 08/08/2013
EMA/CHMP/BWP/310834/2012
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Draft guideline on influenza vaccines: non-clinical and clinical module (PDF/302.99 KB)

Draft guideline on influenza vaccines: non-clinical … non-clinical and clinical module … Draft guideline on influenza vaccines: non-clinical …

Draft: consultation closed
First published: 31/07/2014
Last updated: 31/07/2014
Consultations dates: from 31/07/2014 to 31/01/2015
EMA/CHMP/VWP/457259/2014
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Overview of comments received on guideline on influenza vaccines – Quality module (PDF/220.86 KB)

view of comments received on guideline on influenza vaccines – … influenza vaccines – Quality module … view of comments received on guideline on influenza vaccines – …

First published: 02/06/2014
Last updated: 02/06/2014
Legal effective date: 01/11/2014
EMA/CHMP/BWP/78207/2014
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Overview of comments received on 'Draft guideline on influenza vaccines: non-clinical and clinical module ' (EMA/CHMP/VWP/457259/2014) (PDF/384.26 KB)

comments received on 'Draft guideline on influenza vaccines: non-clinical … non-clinical and clinical module ' (EMA/CHMP/VWP/457259/2014 … comments received on 'Draft guideline on influenza vaccines: non-clinical …

First published: 21/10/2016
Last updated: 21/10/2016
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Appendix IV of the guideline on the investigation on bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1): Presentation of biopharmaceutical and bioanalytical data in module 2.7.1 (PDF/138.26 KB)

Appendix IV of the guideline on the investigation on bioequivalence … and bioanalytical data in module 2.7.1 … Appendix IV of the guideline on the investigation on bioequivalence …

Adopted
First published: 18/11/2011
Last updated: 08/12/2011
Legal effective date: 01/06/2012
EMA/CHMP/600958/2010
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Draft appendix IV of the guideline on the investigation on bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1): Presentation of biopharmaceutical and bioanalytical data in module 2.7.1 (PDF/154.85 KB)

Draft appendix IV of the guideline on the investigation on bioequivalence … and bioanalytical data in module 2.7.1 … Draft appendix IV of the guideline on the investigation on bioequivalence …

Draft: consultation closed
First published: 14/03/2011
Last updated: 14/03/2011
Consultations dates: from 17/02/2011 to 31/05/2011
EMA/CHMP/600958/2010
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Overview of comments received on 'appendix IV of the guideline on the investigation on bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1): Presentation of biopharmaceutical and bioanalytical data in module 2.7.1 (EMA/CHMP/60095... (PDF/231.61 KB)

received on 'appendix IV of the guideline on the investigation on bioequivalence … and bioanalytical data in module 2.7.1 (EMA/CHMP/60095 … received on 'appendix IV of the guideline on the investigation on bioequivalence …

First published: 18/11/2011
Last updated: 18/11/2011
EMA/CHMP/643484/2011
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Influenza vaccines - non-clinical and clinical module (PDF/325.36 KB)

non-clinical and clinical module … non-clinical and clinical module Reference number: EMA/CHMP/VWP/457259/2014 … 29/07/2016 Summary: This guideline on influenza vaccines has …

Adopted
First published: 29/07/2016
Last updated: 29/07/2016
EMA/CHMP/VWP/457259/2014
List item

Draft qualification opinion on Cellular therapy module of the European Society for Blood & Marrow Transplantation (EBMT) Registry (PDF/693.58 KB)

opinion on Cellular therapy module of the European Society for … opinion on Cellular therapy module of the European Society for … opinion on Cellular therapy module of 4 the European Society …

Draft: consultation closed
First published: 29/06/2018
Last updated: 29/06/2018
Consultations dates: from 29/06/2018 to 21/08/2018
EMA/CHMP/SAWP/423488/2018
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Guideline on manufacture of the finished dosage form - Revision 1 (PDF/210.56 KB)

Guideline on manufacture of the finished … Download document Guideline on manufacture of the finished … 14/08/2017 Summary: This guideline replaces the note for guidance …

Adopted
First published: 14/08/2017
Last updated: 14/08/2017
EMA/CHMP/QWP/245074/2015
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Draft guideline on manufacture of the finished dosage form - Revision 1 (PDF/306.54 KB)

Draft guideline on manufacture of the finished … Download document Draft guideline on manufacture of the finished … qwp@ema.europa.eu Summary: This guideline replaces the note for guidance …

Draft: consultation closed
First published: 09/07/2015
Last updated: 09/07/2015
Consultations dates: from 09/07/2015 to 09/01/2016
EMA/CHMP/QWP/245074/2015
List item

Guideline on quality of herbal medicinal products traditional herbal medicinal products - Revision 2 (PDF/117 KB)

Guideline on quality of herbal medicinal … Download document Guideline on quality of herbal medicinal … 28/09/2011 Summary: This guideline concerns the application of Module 3 of Annex I to Directive …

Adopted
First published: 28/09/2011
Last updated: 28/09/2011
EMA/HMPC/201116/2005 Rev. 2
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News: European Medicines Agency finalises update to guideline on renewals

CHMP, Last updated: 02/07/2012

Agency finalises update to guideline on renewals … Agency finalises update to guideline on renewals … Medicinal Products (CHMP) Guideline on the processing of renewals …
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Overview of comments received on draft revision 2 of the SmPC guideline - Proposal for a revision of the European Commission guideline on summary of product characteristics (PDF/802.38 KB)

draft revision 2 of the SmPC guideline - Proposal for a revision … of the European Commission guideline on summary of product charact … draft revision 2 of the SmPC guideline - Proposal for a revision …

First published: 22/10/2009
Last updated: 22/10/2009
EMEA/CHMP/663087/2009
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News: Revised guideline on quality of biosimilar medicines open for comments

CHMP, Last updated: 31/05/2012

Revised guideline on quality of biosimilar … Revised guideline on quality of biosimilar … Products for Human Use (CHMP) Guideline on similar biological medicinal …
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News: European Medicines Agency updates guideline on drug interactions

CHMP, Last updated: 06/07/2012

Medicines Agency updates guideline on drug interactions … Medicines Agency updates guideline on drug interactions … Guideline on the investigation of drug …
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Implementation strategy of ICH Q3D guideline (PDF/105.8 KB)

entation strategy of ICH Q3D guideline … entation strategy of ICH Q3D guideline … entation strategy of ICH Q3D guideline 30 Churchill Place …

Adopted
First published: 08/03/2017
Last updated: 08/03/2017
EMA/CHMP/QWP/115498/2017
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News: European Medicines Agency finalises update to Parkinson's disease guideline

CHMP, Last updated: 06/07/2012

update to Parkinson's disease guideline … update to Parkinson's disease guideline … Products for Human Use (CHMP) Guideline on clinical investigation …
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Guideline on the chemistry of active substances (PDF/203.56 KB)

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

Adopted
First published: 21/11/2016
Last updated: 21/11/2016
Legal effective date: 21/01/2017
EMA/454576/2016
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Guideline on immunogenicity assessment of therapeutic proteins - Revision 1 (PDF/263.08 KB)

Guideline on immunogenicity assessment … Guideline on immunogenicity assessment … Guideline on Immunogenicity assessment …

Adopted
First published: 01/06/2017
Last updated: 01/06/2017
Legal effective date: 01/12/2017
EMEA/CHMP/BMWP/14327/2006 Rev 1
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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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Guideline on similar biological medicinal products (Rev.1) (PDF/120.46 KB)

Guideline on similar biological medicinal … Guideline on similar biological medicinal … Products for Human Use (CHMP) Guideline on similar biological medicinal …

Adopted
First published: 29/10/2014
Last updated: 29/10/2014
Legal effective date: 30/04/2015
CHMP/437/04 Rev.1
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Guideline on plasma-derived medicinal products (PDF/323.79 KB)

Guideline on plasma-derived medicinal … Guideline on plasma-derived medicinal … Guideline on plasma-derived medicinal …

Adopted
First published: 29/07/2011
Last updated: 29/07/2011
EMA/CHMP/BWP/706271/2010

2143 results

Guideline on Influenza vaccines – Quality module Revision 1 (PDF/345.62 KB)

Guideline on influenza vaccines – Quality module (PDF/283.56 KB)

Draft guideline on influenza vaccines – quality module (PDF/277.15 KB)

Draft guideline on influenza vaccines: non-clinical and clinical module (PDF/302.99 KB)

Overview of comments received on guideline on influenza vaccines – Quality module (PDF/220.86 KB)

Overview of comments received on 'Draft guideline on influenza vaccines: non-clinical and clinical module ' (EMA/CHMP/VWP/457259/2014) (PDF/384.26 KB)

Appendix IV of the guideline on the investigation on bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1): Presentation of biopharmaceutical and bioanalytical data in module 2.7.1 (PDF/138.26 KB)

Draft appendix IV of the guideline on the investigation on bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1): Presentation of biopharmaceutical and bioanalytical data in module 2.7.1 (PDF/154.85 KB)

Overview of comments received on 'appendix IV of the guideline on the investigation on bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1): Presentation of biopharmaceutical and bioanalytical data in module 2.7.1 (EMA/CHMP/60095... (PDF/231.61 KB)

Influenza vaccines - non-clinical and clinical module (PDF/325.36 KB)

Draft qualification opinion on Cellular therapy module of the European Society for Blood & Marrow Transplantation (EBMT) Registry (PDF/693.58 KB)

Guideline on manufacture of the finished dosage form - Revision 1 (PDF/210.56 KB)

Draft guideline on manufacture of the finished dosage form - Revision 1 (PDF/306.54 KB)

Guideline on quality of herbal medicinal products traditional herbal medicinal products - Revision 2 (PDF/117 KB)

News: European Medicines Agency finalises update to guideline on renewals

Overview of comments received on draft revision 2 of the SmPC guideline - Proposal for a revision of the European Commission guideline on summary of product characteristics (PDF/802.38 KB)

News: Revised guideline on quality of biosimilar medicines open for comments

News: European Medicines Agency updates guideline on drug interactions

Implementation strategy of ICH Q3D guideline (PDF/105.8 KB)

News: European Medicines Agency finalises update to Parkinson's disease guideline

Guideline on the chemistry of active substances (PDF/203.56 KB)

Guideline on immunogenicity assessment of therapeutic proteins - Revision 1 (PDF/263.08 KB)

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

Guideline on similar biological medicinal products (Rev.1) (PDF/120.46 KB)

Guideline on plasma-derived medicinal products (PDF/323.79 KB)