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Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract - Revision 1 (PDF/455.51 KB)

Adopted
First published: 07/11/2018
Last updated: 29/04/2019
Legal effective date: 30/04/2019
CPMP/EWP/239/95 Rev. 1 Corr.
List item

Draft guideline on clinical investigation of recombinant and human plasma-derived factor IX products - Revision 2 (PDF/575.99 KB)

Draft: consultation open
First published: 30/11/2018
Last updated: 19/12/2018
Consultations dates: from 03/12/2018 to 30/06/2019
EMA/CHMP/BPWP/144552/2009 rev. 2 Corr.1
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Reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH) (PDF/422.33 KB)

Draft: consultation open
First published: 19/11/2018
Last updated: 12/12/2018
Consultations dates: from 19/11/2018 to 31/08/2019
EMA/CHMP/299976/2018
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Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (PDF/225.59 KB)

Adopted
First published: 09/10/2017
Last updated: 19/11/2018
EMA/CHMP/302620/2017 Corr.1
Bulgarian
(PDF/272.35 KB)

Croatian
(PDF/240.11 KB)

Czech
(PDF/242.51 KB)

Danish
(PDF/197.59 KB)

Dutch
(PDF/195.96 KB)

Estonian
(PDF/169.67 KB)

Finnish
(PDF/189.45 KB)

French
(PDF/211.05 KB)

German
(PDF/197.27 KB)

Greek
(PDF/273.31 KB)

Hungarian
(PDF/263.5 KB)

Icelandic
(PDF/193.18 KB)

Italian
(PDF/189.51 KB)

Latvian
(PDF/246.73 KB)

Lithuanian
(PDF/246.73 KB)

Maltese
(PDF/225.26 KB)

Norwegian
(PDF/190.38 KB)

Polish
(PDF/236.94 KB)

Portuguese
(PDF/185.3 KB)

Romanian
(PDF/242.59 KB)

Slovak
(PDF/240.82 KB)

Slovenian
(PDF/228.38 KB)

Spanish
(PDF/200.65 KB)

Swedish
(PDF/168.01 KB)
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Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use (PDF/132.89 KB)

Adopted
First published: 09/10/2017
Last updated: 19/11/2018
EMA/CHMP/606830/2014 Corr.1
List item

Information for the package leaflet regarding aspartame and phenylalanine used as excipients in medicinal products for human use (PDF/330.41 KB)

Adopted
First published: 09/10/2017
Last updated: 19/11/2018
EMA/CHMP/134648/2015 Corr.1
List item

Questions and answers on wheat starch (containing gluten) used as an excipient in medicinal products for human use (PDF/131.08 KB)

Adopted
First published: 09/10/2017
Last updated: 19/11/2018
EMA/CHMP/704219/2013 Corr.1
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Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - Revision 1 (PDF/210.49 KB)

Adopted
First published: 26/10/2017
Last updated: 07/11/2018
Legal effective date: 26/04/2018
EMA/CHMP/BWP/534898/2008 Rev. 1 corrigendum
List item

Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1 (PDF/91.07 KB)

Draft: consultation closed
First published: 17/09/2018
Last updated: 17/09/2018
Consultations dates: from 17/09/2018 to 16/12/2018
EMA/PDCO/362462/2016
List item

Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3 (PDF/727.6 KB)

Draft: consultation closed
First published: 17/08/2018
Last updated: 17/08/2018
Consultations dates: from 17/08/2018 to 17/02/2019
CHMP/EWP/566/98
List item

Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1 (PDF/150.49 KB)

Draft: consultation closed
First published: 15/08/2018
Last updated: 15/08/2018
Consultations dates: from 15/08/2018 to 15/02/2019
EMEA/CHMP/BMWP/31329/2005
List item

Guideline on core summary for product characteristics for human albumin solution - Revision 3 (PDF/122.8 KB)

Adopted
First published: 13/08/2018
Last updated: 13/08/2018
Legal effective date: 01/02/2019
EMA/CHMP/BPWP/494462/2011
List item

Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products - Revision 2 (PDF/492.58 KB)

Adopted
First published: 13/08/2018
Last updated: 13/08/2018
Legal effective date: 01/02/2019
EMA/CHMP/BPWP/144533/2009
List item

Guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products - Revision 3 (PDF/191.38 KB)

Adopted
First published: 13/08/2018
Last updated: 13/08/2018
Legal effective date: 01/02/2019
EMA/CHMP/BPWP/1619/1999
List item

Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies (PDF/126.46 KB)

Draft: consultation closed
First published: 06/08/2018
Last updated: 06/08/2018
Consultations dates: from 06/08/2018 to 31/10/2018
EMA/CHMP/459559/2018
List item

ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version (PDF/351.95 KB)

Draft: consultation closed
First published: 06/08/2018
Last updated: 06/08/2018
Consultations dates: from 06/08/2018 to 06/02/2019
EMA/CHMP/ICH/493213/2018
List item

Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance (PDF/76.7 KB)

Adopted
First published: 03/08/2018
Last updated: 03/08/2018
EMA/CHMP/800789/2017
List item

Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance (PDF/91.2 KB)

Adopted
First published: 03/08/2018
Last updated: 03/08/2018
EMA/CHMP/800785/2017
List item

Agomelatine tablet 25 mg product-specific bioequivalence guidance (PDF/83.4 KB)

Adopted
First published: 03/08/2018
Last updated: 03/08/2018
EMA/CHMP/800802/2017
List item

Vismodegib hard capsule 150 mg product-specific bioequivalence guidance (PDF/76.37 KB)

Adopted
First published: 03/08/2018
Last updated: 03/08/2018
EMA/CHMP/800794/2017
List item

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance (PDF/83.54 KB)

Adopted
First published: 03/08/2018
Last updated: 03/08/2018
EMA/CHMP/800759/2017
List item

Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells (PDF/322.12 KB)

Draft: consultation open
First published: 31/07/2018
Last updated: 31/07/2018
Consultations dates: from 31/07/2018 to 31/07/2019
EMA/CAT/GTWP/671639/2008 Rev. 1
List item

Concept paper on the need to develop a reflection paper on development of medicinal products to prevent and treat acute kidney injury (PDF/177.01 KB)

Draft: consultation open
First published: 09/07/2018
Last updated: 30/07/2018
Consultations dates: from 30/07/2018 to 01/08/2019
EMA/CHMP/171100/2018 Corr.
List item

Guideline on the development of new medicinal products for the treatment of Ulcerative Colitis - Revision 1 (PDF/255.82 KB)

Adopted
First published: 23/07/2018
Last updated: 23/07/2018
Legal effective date: 01/01/2019
CHMP/EWP/18463/2006 Rev.1
List item

Guideline on the development of new medicinal products for the treatment of Crohn’s Disease - Revision 2 (PDF/208.71 KB)

Adopted
First published: 23/07/2018
Last updated: 23/07/2018
Legal effective date: 01/01/2019
CPMP/EWP/2284/99 Rev. 2

1216 results

Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract - Revision 1 (PDF/455.51 KB)

Draft guideline on clinical investigation of recombinant and human plasma-derived factor IX products - Revision 2 (PDF/575.99 KB)

Reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH) (PDF/422.33 KB)

Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (PDF/225.59 KB)

Questions and answers on sodium laurilsulfate used as an excipient in medicinal products for human use (PDF/132.89 KB)

Information for the package leaflet regarding aspartame and phenylalanine used as excipients in medicinal products for human use (PDF/330.41 KB)

Questions and answers on wheat starch (containing gluten) used as an excipient in medicinal products for human use (PDF/131.08 KB)

Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials - Revision 1 (PDF/210.49 KB)

Concept paper on the need for revision of the guideline on the investigation of medicinal products in the term and preterm neonate - Revision 1 (PDF/91.07 KB)

Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3 (PDF/727.6 KB)

Draft guideline on similar biological medicinal products containing recombinant granulocyte-colony stimulating factor (rG-CSF) - Revision 1 (PDF/150.49 KB)

Guideline on core summary for product characteristics for human albumin solution - Revision 3 (PDF/122.8 KB)

Guideline on the clinical investigation of recombinant and human plasma-derived factor VIII products - Revision 2 (PDF/492.58 KB)

Guideline on core SmPC for human plasma derived and recombinant coagulation factor VIII products - Revision 3 (PDF/191.38 KB)

Draft guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies (PDF/126.46 KB)

ICH M9 on biopharmaceutics classification system based biowaivers - Step 2b - First version (PDF/351.95 KB)

Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance (PDF/76.7 KB)

Posaconazole gastro-resistant tablet 100 mg product-specific bioequivalence guidance (PDF/91.2 KB)

Agomelatine tablet 25 mg product-specific bioequivalence guidance (PDF/83.4 KB)

Vismodegib hard capsule 150 mg product-specific bioequivalence guidance (PDF/76.37 KB)

Cholic acid capsules 50 mg and 250 mg product-specific bioequivalence guidance (PDF/83.54 KB)

Draft guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells (PDF/322.12 KB)

Concept paper on the need to develop a reflection paper on development of medicinal products to prevent and treat acute kidney injury (PDF/177.01 KB)

Guideline on the development of new medicinal products for the treatment of Ulcerative Colitis - Revision 1 (PDF/255.82 KB)

Guideline on the development of new medicinal products for the treatment of Crohn’s Disease - Revision 2 (PDF/208.71 KB)