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Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668) - Superseded (PDF/803.95 KB) (updated)

Adopted
First published: 09/10/2017
Last updated: 22/11/2019
Legal effective date: 09/10/2017
EMA/CHMP/302620/2017 Corr.1
Bulgarian
(PDF/839.88 KB)

Croatian
(PDF/817.47 KB)

Czech
(PDF/820.69 KB)

Danish
(PDF/775.32 KB)

Dutch
(PDF/774.1 KB)

Estonian
(PDF/748.01 KB)

Finnish
(PDF/768.01 KB)

French
(PDF/796.79 KB)

German
(PDF/777.2 KB)

Greek
(PDF/851.84 KB)

Hungarian
(PDF/830.38 KB)

Icelandic
(PDF/770.42 KB)

Italian
(PDF/767.61 KB)

Latvian
(PDF/825.2 KB)

Lithuanian
(PDF/826.31 KB)

Maltese
(PDF/804.36 KB)

Norwegian
(PDF/769.45 KB)

Polish
(PDF/817.25 KB)

Portuguese
(PDF/765.58 KB)

Romanian
(PDF/821.81 KB)

Slovak
(PDF/818.86 KB)

Slovenian
(PDF/805.68 KB)

Spanish
(PDF/703.08 KB)

Swedish
(PDF/745.16 KB)
List item

ICH guideline Q3C (R6) on impurities - support document 3: toxicological data for class 3 solvents - Step 5 (PDF/629.14 KB)

First published: 26/10/2018
Last updated: 15/10/2019
EMA/CHMP/ICH/735038/2018
List item

ICH guideline Q3C (R6) on impurities - support document 2: toxicological data for class 2 solvents - Step 5 (PDF/1006.19 KB)

First published: 26/10/2018
Last updated: 15/10/2019
EMA/CHMP/ICH/735036/2018
List item

ICH guideline Q3C (R6) on impurities - support document 1: toxicological data for class 1 solvents - Step 5 (PDF/644.27 KB)

First published: 26/10/2018
Last updated: 15/10/2019
EMA/CHMP/ICH/735035/2018
List item

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline Q3C (R6) on impurities: guideline for residual solvents - Step 5 (PDF/498.12 KB)

Adopted
First published: 26/10/2018
Last updated: 08/10/2019
Legal effective date: 14/06/2017
EMA/CHMP/ICH/82260/2006
List item

Fingolimod capsules 0.25 and 0.5 mg product-specific bioequivalence guidance (PDF/174.37 KB)

Adopted
First published: 03/01/2017
Last updated: 09/08/2019
Legal effective date: 01/07/2017
EMA/CHMP/154812/2016 Rev.1 Corr.
List item

Draft guideline on clinical investigation of medicinal products for the treatment of gout - First version (PDF/331.79 KB)

Draft: consultation closed
First published: 08/02/2019
Last updated: 07/08/2019
Consultations dates: from 08/02/2019 to 31/08/2019
EMA/CHMP/774470/2018
List item

Draft qualification opinion of Multiple sclerosis clinical outcome assessment (MSCOA) (PDF/1.08 MB)

Draft: consultation closed
First published: 19/06/2019
Last updated: 02/07/2019
Consultations dates: from 18/06/2019 to 20/09/2019
EMA/CHMP/SAWP/336445/2019 Corr.1
List item

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 closed
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
List item

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 closed
First published: 19/11/2018
Last updated: 12/12/2018
Consultations dates: from 19/11/2018 to 31/08/2019
EMA/CHMP/299976/2018
List item

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
List item

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

Draft 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

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

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

1234 results

Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ (SANTE-2017-11668) - Superseded (PDF/803.95 KB) (updated)

ICH guideline Q3C (R6) on impurities - support document 3: toxicological data for class 3 solvents - Step 5 (PDF/629.14 KB)

ICH guideline Q3C (R6) on impurities - support document 2: toxicological data for class 2 solvents - Step 5 (PDF/1006.19 KB)

ICH guideline Q3C (R6) on impurities - support document 1: toxicological data for class 1 solvents - Step 5 (PDF/644.27 KB)

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline Q3C (R6) on impurities: guideline for residual solvents - Step 5 (PDF/498.12 KB)

Fingolimod capsules 0.25 and 0.5 mg product-specific bioequivalence guidance (PDF/174.37 KB)

Draft guideline on clinical investigation of medicinal products for the treatment of gout - First version (PDF/331.79 KB)

Draft qualification opinion of Multiple sclerosis clinical outcome assessment (MSCOA) (PDF/1.08 MB)

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)

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)

Draft 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)

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

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