Open consultations

The list below includes the European Medicines Agency's (EMA) open public consultations.
HumanVeterinaryScientific guidelines

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 Ko - DOC)

First published:
Voir

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 Ko - XLSX)

First published:
Voir

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 Ko - PDF)

First published:
Voir

Open consultations

Concept paper for the development of a reflection paper on the use of Bayesian methods in clinical development

Draft: consultation open Consultation dates: to Reference Number: EMA/CHMP/1813/2026 Summary:

The purpose of the proposed guideline is to address key considerations for studies that utilise Bayesian statistics in clinical development.

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

English (EN) (219.97 Ko - PDF)

First published:
Voir

Concept paper on the revision of the guideline on clinical evaluation of diagnostic agents and its appendix 1 on imaging agents

Draft: consultation open Consultation dates: to Reference Number: EMA/4366/2026 Summary:

The proposed guideline will replace the Guideline on clinical evaluation of diagnostic agents (CPMP/EWP/1119/98/Rev. 1) and the Appendix 1 to the guideline on clinical evaluation of diagnostic agents (CPMP/EWP/1119/98 REV. 1) on imaging agents (EMEA/CHMP/EWP/321180/2008).

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

English (EN) (222.31 Ko - PDF)

First published:
Voir

Concept paper on the development of a guideline for using owner assessment as efficacy parameter

Draft: consultation open Consultation dates: to Reference Number: EMA/CVMP/EWP/364649/2025 Summary:

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

English (EN) (163.97 Ko - PDF)

First published:
Voir

Draft guideline on veterinary medicinal products controlling Varroa destructor parasitosis in bees - Revision 2

Draft: consultation open Consultation dates: to Reference Number: EMA/CVMP/EWP/459883/2008 Rev.2 Summary:

This revision will replace the current version of the CVMP guideline on veterinary medicinal products controlling Varroa destructor parasitosis in bees (EMA/CVMP/EWP/459883/2008-Rev.1).
Comments should be provided using this template. The completed comments form should be sent to vet-guidelines@ema.europa.eu 

English (EN) (320.48 Ko - PDF)

First published:
Voir

Draft guideline for the evaluation of efficacy of ectoparasiticides - general requirements

Draft: consultation open Consultation dates: to Reference Number: EMA/CVMP/EWP/507106/2023 Summary:

This guideline replaces the 'Guideline for demonstration of efficacy of ectoparasiticides' (7AE17a).

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

English (EN) (339.68 Ko - PDF)

First published:
Voir

Draft guideline on the requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs) - Revision 1

Draft: consultation open Consultation dates: to Reference Number: EMA/CVMP/IWP/365787/2025-Rev.1 Summary:

This guideline replaces the current version of the Guideline on the requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs) (EMA/CVMP/IWP/594618/2010). The guideline was revised in order to adapt legal references to the current legislation and reflect the experience that was gained with the guideline since it is in force. In addition, new approaches in vaccine development and alternative approaches to assess the absence of immunological interference in the associated use of vaccines are considered in the revision. This information is also included in the guideline. 

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

English (EN) (368.82 Ko - PDF)

First published:
Voir

Reflection paper on investigation and assessment of cardiovascular safety of anticancer medicinal products

Draft: consultation open Consultation dates: to Reference Number: EMA/8699/2026 Summary:

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

English (EN) (264.64 Ko - PDF)

First published:
Voir

Concept Paper on the revision of Annex 3 of the guidelines on Good Manufacturing Practice for Radiopharmaceuticals

Draft: consultation open Consultation dates: to Reference Number: EMA/INS/GMP/389655/2025 Summary:

This concept paper aims to outline the rationale, objectives, and proposed changes for updating the Annex 3, Manufacture of Radiopharmaceuticals, of the Good Manufacturing Practice (GMP) guide, that is common to the Member States of the European Union (EU)/European Economic Area (EEA) as well as to the Participating Authorities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The aim of the revision is to provide guidance within some areas that were not covered in the current version issued in 2008, clarify some sections, and support innovative pharmaceutical manufacturing and control approaches.

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

English (EN) (197.45 Ko - PDF)

First published: Last updated:
Voir

ICH E22 Guideline on general considerations for patient preference studies - Step 2b

Draft: consultation open Consultation dates: to Reference Number: EMA/CHMP/ICH/371537/2025 Summary:

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

English (EN) (1.1 Mo - PDF)

First published:
Voir

Draft guideline on quality of radiopharmaceuticals - Revision 2

Draft: consultation open Consultation dates: to Reference Number: EMA/CHMP/QWP/363827/2025 Summary:

This guideline replaces the ‘Guideline on Radiopharmaceuticals’ (EMEA/CHMP/QWP/306970/2007). Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

English (EN) (505.5 Ko - PDF)

First published:
Voir

Concept paper on the guideline revision on good pharmacogenomic practice

Draft: consultation open Consultation dates: to Reference Number: EMA/282050/2025 Summary:

The proposed revised guideline will replace the 'Guideline on good pharmacogenomic practice' (EMA/CHMP/718998/2016). Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

English (EN) (227.13 Ko - PDF)

First published: Last updated:
Voir

Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of Parkinson’s disease

Draft: consultation open Consultation dates: to Reference Number: EMA/322471/2025 Summary:

The proposed guideline will replace the Guideline on clinical investigation of medicinal products in the treatment of Parkison’s disease (EMA/CHMP/330418/2012 rev. 2, 7 July 2012).

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

English (EN) (207.78 Ko - PDF)

First published:
Voir

Concept paper for the development of a guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in non-food-producing animal species

Draft: consultation open Consultation dates: to Reference Number: EMA/CVMP/AWP/109142/2025 Summary:

This concept paper proposes the development of a guideline to provide advice on data requirements and methodology for assessing the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product (VMP) in non-food-producing animal species to address regulatory requirements laid in Regulation (EU) 2019/6. In view of the experience and knowledge with antimicrobials for pets, the intended guideline will be developed with a focus on companion animals, although all non-food-producing animals are in scope.

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

English (EN) (237.08 Ko - PDF)

First published:
Voir

Draft guideline on non-inferiority and equivalence comparisons in clinical trials

Draft: consultation open Consultation dates: to Reference Number: EMA/301654/2025 Summary:

This guideline replaces the 'Guideline on the choice of the non-inferiority margin' (EMEA/CPMP/EWP/2158/99) and ‘Points to consider on switching between superiority and non-inferiority' (CPMP/EWP/482/99).

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

English (EN) (498.78 Ko - PDF)

First published:
Voir

Draft guideline on quality aspects of phage therapy medicinal products

Draft: consultation open Consultation dates: to Reference Number: EMA/CHMP/BWP/1/2024 Summary:

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

English (EN) (338.3 Ko - PDF)

First published:
Voir

Draft guideline on the clinical evaluation of medicinal products intended for the treatment of chronic hepatitis B (CHB) - Revision 1

Draft: consultation open Consultation dates: to Reference Number: EMA/283093/2016 Rev. 1 Summary:

This guideline replaces the guideline on the clinical evaluation of medicinal products intended for the treatment of Hepatitis B (CHMP/EWP/6172/03). Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

English (EN) (416.36 Ko - PDF)

First published:
Voir

Draft guideline on clinical investigation of medicinal products for the treatment of psoriatic arthritis - Revision 1

Draft: consultation open Consultation dates: to Reference Number: CHMP/EWP/438/04 Rev. 1 Summary:

This guideline replaces the ‘guideline on clinical investigation of medicinal products for the treatment of psoriatic arthritis' (CHMP/EWP/438/04). Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

English (EN) (424.23 Ko - PDF)

First published:
Voir

VICH GL62 on target animal safety of veterinary monoclonal antibody products (VMAPs)

Draft: consultation open Consultation dates: to Reference Number: EMA/CVMP/VICH/250843/2021 Summary:

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

English (EN) (423.55 Ko - PDF)

First published:
Voir

Concept paper on the need for revision of the guideline on the clinical investigation of medicines for the treatment of Alzheimer's disease

Draft: consultation open Consultation dates: to Reference Number: EMA/231314/2025 Summary:

The proposed guideline will replace 'Guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease' (CPMP/EWP/553/95 Rev.2 Corr.1*).

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

English (EN) (189.34 Ko - PDF)

First published:
Voir

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