Open consultations

To reply to a consultation, please use the dedicated EUSurvey link included in the relevant consultation document.

In case this link is not available, you can use the form below for comments:

Templates

Template for submission of comments on scientific guidelines

English (EN) (232 KB - DOC)

First published: 27/01/2023

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To submit comments specifically on ICH draft guidelines under consultation, use the form below:

Template for submission of comments on ICH guidelines

English (EN) (208.69 KB - XLSX)

First published: 15/02/2023

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Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see:

European Medicines Agency’s privacy statement public and targeted consultations

Reference Number: EMA/472380/2019

English (EN) (134.32 KB - PDF)

First published: 14/02/2020

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Concept paper on the need for revision of note for guidance on quality aspects of pharmaceutical veterinary medicines for administration via drinking water

Draft: consultation openConsultation dates: 20/06/2025 to 31/10/2025Reference Number: EMA/CVMP/QWP/85848/2025Summary:

This concept paper addresses the need to complement the guideline on Quality Aspects of Pharmaceutical Veterinary Medicines for administration via drinking water (EMEA/CVMP/540/03 Rev.1) with information relating to the administration of veterinary medicinal products in liquid feeds.

Comments should be provided using this EUSurvey form. For any technical issues, please contact
the EUSurvey Support.

English (EN) (148.26 KB - PDF)

First published: 20/06/2025

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Concept paper for the development of a guideline on the methodology of environmental risk assessment for ectoparasiticidal VMPs for cats and dogs

Draft: consultation openConsultation dates: 20/06/2025 to 31/10/2025Reference Number: EMA/CVMP/ERA/499198/2024Summary:

This concept paper aims to outline the CVMP's approach regarding the elaboration of guidance on the assessment methodology to be used where the current default assumptions are not considered to be appropriate for ectoparasiticidal VMPs, including the nature of data to be provided in such cases.

Comments should be provided using this template. The completed comments form should be sent to vet-guidelines@ema.europa.eu

English (EN) (256.32 KB - PDF)

First published: 20/06/2025

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Draft chapter 9 of guideline on epidemiological data on blood transmissible infections

Draft: consultation openConsultation dates: 18/06/2025 to 31/08/2025Reference Number: EMA/CHMP/BWP/548524/2008 rev 2Summary:

This revision is only revising chapter 9 of the full guideline: Guideline for epidemiological data on blood transmissible infections. Upon finalisation the chapter 9 will be merged in the full guideline.

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

English (EN) (345.61 KB - PDF)

First published: 19/06/2025

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ICH E21 Guideline on inclusion of pregnant and breastfeeding individuals in clinical trials

Draft: consultation openConsultation dates: 04/06/2025 to 15/09/2025Reference Number: EMA/CHMP/ICH/149462/2025Summary:

Comments should be provided using this template. The completed comments form should be sent to ich@ema.europa.eu.

English (EN) (1001.8 KB - PDF)

First published: 04/06/2025

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Draft European Union herbal monograph on Ononis spinosa L., radix - Revision 1

Draft: consultation openConsultation dates: 01/06/2025 to 31/08/2025Reference Number: EMA/HMPC/584455/2023 Rev 1Summary:

Comments should be provided using this template to hmpc.secretariat@ema.europa.eu

English (EN) (264.28 KB - PDF)

First published: 02/06/2025

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Draft reflection paper on data recommendations for herbal medicinal products and traditional herbal medicinal products used in children and adolescents

Draft: consultation openConsultation dates: 01/06/2025 to 31/08/2025Reference Number: EMA/HMPC/71333/2023Summary:

Comments should be provided using this template to hmpc.secretariat@ema.europa.eu

English (EN) (292.63 KB - PDF)

First published: 02/06/2025

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Concept paper on the development of a guideline on consumer safety of active substances of immunological veterinary medicinal products acting against endogenous targets

Draft: consultation openConsultation dates: 23/05/2025 to 31/08/2025Reference Number: EMA/CVMP/SWP/564861/2023Summary:

Comments should be provided using this template. The completed comments form should be sent to vet-guidelines@ema.europa.eu

English (EN) (190.9 KB - PDF)

First published: 23/05/2025

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Concept paper on the revision of Part IV guidelines on good manufacturing practice specific to advanced therapy medicinal products

Draft: consultation openConsultation dates: 08/05/2025 to 08/07/2025Reference Number: EMA/INS/GMP/48771/2025Summary:

This concept paper aims to outline the rationale, objectives, and proposed changes for updating Part IV – GMP specific to ATMP of the good manufacturing practice (GMP) guide Eudralex Volume 4 following the revision of Annex 1 which came into operation in August 2023. As the Part IV is an EU standalone guideline and that the sector is to abide solely for reference, it should be revised independently to address recent developments in the manufacture of sterile medicinal products.

Those participating in the public consultation are asked to please submit comments via the EU Survey tool.

English (EN) (113.06 KB - PDF)

First published: 08/05/2025

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Concept paper on the revision of the guideline on the evaluation of anticancer medicinal products and appendices - Revision 7

Draft: consultation openConsultation dates: 30/04/2025 to 31/07/2025Reference Number: EMA/122980/2025

English (EN) (208.59 KB - PDF)

First published: 30/04/2025

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Draft ICH Q1 guideline on stability testing of drug substances and drug products - Step 2b

Draft: consultation openConsultation dates: 30/04/2025 to 30/07/2025Reference Number: EMA/CHMP/ICH/130561/2025Summary:

Comments should be provided using this template. The completed comments form should be sent to ich@ema.europa.eu

English (EN) (2.1 MB - PDF)

First published: 30/04/2025

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Concept paper for the development of a reflection paper on the assessment of public health risks related to antimicrobial resistance acquired via the environment, resulting from the use of a veterinary medicinal product

Draft: consultation openConsultation dates: 16/04/2025 to 31/10/2025Reference Number: EMA/CVMP/ERA/75412/2023Summary:

This concept paper provides background to the intended development of a scientific approach for use in the evaluation of the risk for humans exposed to antimicrobial resistance via the environment, originating from use of veterinary medicinal products. It is intended to provide advice on how relevant dossier requirements outlined in Regulation (EU) 2019/6 (e.g., Article 8(2)) may be fulfilled.

Comments should be provided using this template. The completed comments form should be sent to vet-guidelines@ema.europa.eu

English (EN) (234.71 KB - PDF)

First published: 16/04/2025

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Call for scientific data for the use in HMPC assessment work on Valerianae radix and Passiflorae herba

Draft: consultation openConsultation dates: 15/04/2025 to 15/07/2025Reference Number: EMA/HMPC/125437/2025

English (EN) (119.82 KB - PDF)