Open consultations
Browse the European Medicines Agency's open public consultations and find information on how to submit your comments.
HumanVeterinaryHerbalScientific guidelines
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Use the dedicated EUSurvey link or consultation document template in the relevant consultation document to submit your comments.
EMA publishes all comments received during the consultation on the dedicated guidance page.
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Templates
Below is the standard consultation document template. However, always check the template needed in the relevant consultation document.
Template for submission of comments on scientific guidelines
English (EN) (232 KB - DOC)
Ippubblikat għall-ewwel darba:
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)
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Open consultations
Draft guideline on veterinary good pharmacovigilance practices (VGVP) - List of medically important (MI) VeDDRA terms
Draft: consultation open
Consultation dates:
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Reference Number: EMA/CVMP/PhVWP/220641/2026
Summary:
This guideline replaces the Guideline on veterinary good pharmacovigilance practices (VGVP) Module: Signal Management Appendix 1. Medically Important (MI) VeDDRA terms list (EMA/522332/2021).
Comments should be provided using this template. The completed comments form should be sent to vet-guidelines@ema.europa.eu
English (EN) (293.44 KB - PDF)
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VICH GL49: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food producing animals: validation of analytical methods used in residue depletion studies - Revision 2
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CVMP/VICH/463202/2009
English (EN) (766.79 KB - PDF)
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Draft guideline on risk assessment of medicinal products in human reproduction and breastfeeding: from data to product information - Revision 1
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CHMP/PRAC/203927/2005 Rev.1
Summary:
This guideline replaces Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling (EMEA/CHMP/203927/2005).
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (795.9 KB - PDF)
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Draft guideline on predictive biomarker assays in the context of medicinal product lifecycle
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CHMP/800914/2016
Summary:
This guideline replaces the Concept paper on predictive biomarker-based assay development in the context of drug development and lifecycle (EMA/CHMP/800914/2016).
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (509.04 KB - PDF)
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Raltegravir product-specific bioequivalence guidance 400 mg and 600 mg film-coated tablet, 25 and 100 mg chewable tablet, 100 mg granules for oral suspension
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/200229/2026
Summary:
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (134.97 KB - PDF)
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Niraparib hard capsules 100 mg and film-coated tablets 100 mg product-specific bioequivalence guidance
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/200148/2026
Summary:
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (129.39 KB - PDF)
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Semaglutide tablet 1.5, 4, 9, 25 and 50 mg product-specific bioequivalence guidance
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/198690/2026
Summary:
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (142.38 KB - PDF)
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Draft Data Quality Framework (DQF) for EU medicines regulation: application to collection, management and submission of Adverse Drug Reaction reports
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/87692/2025
Summary:
The Adverse Drug Reaction chapter of the Data Quality Framework is open for public consultation from 19 October to 14 December 2026.
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (1.38 MB - PDF)
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Reflection paper on methodological aspects in confirmatory platform trials
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/217509/2026
Summary:
The aim of this reflection paper is to complement existing guidance documents, e.g. on multiplicity and adaptive designs, not to replace or revise them.
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (435.27 KB - PDF)
Ippubblikat għall-ewwel darba:
Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of hypertension (EMA/CHMP/29947/2013/Rev.4)
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CHMP/219360/2026
Summary:
The proposed revision aims at amending several aspects of the current guideline to reflect new developments in the diagnostic and therapeutic field.
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (193.87 KB - PDF)
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Concept paper on clinical trials in recipients of kidney transplantation
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CHMP/202359/2026
Summary:
The purpose of this concept paper is to update the overarching guideline (Guideline on Clinical Investigation of Immunosuppressants for Solid Organ Transplantation (CHMP/EWP/263148/06) ). The update concerns adult recipients of kidney transplants.
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (192.2 KB - PDF)
Ippubblikat għall-ewwel darba:
Draft reflection paper on the investigation of drug interactions of herbal medicinal products
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/HMPC/362638/2025
Summary:
The purpose of this reflection paper is to provide specific recommendations on how drug interaction issues can be investigated and reported for (T)HMP applications. The reflection paper should be read in conjunction with Directive 2001/83/EC, as well as relevant European Union (EU) guidelines, including Notice to Applicants.
Comments should be provided using this template to hmpc.secretariat@ema.europa.eu
English (EN) (271.64 KB - PDF)
Ippubblikat għall-ewwel darba:
Concept paper on the need for the guideline on the clinical investigation of medicinal products for the treatment of inherited retinal dystrophies
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/219696/2026
Summary:
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (198.01 KB - PDF)
Ippubblikat għall-ewwel darba:
Draft guideline on the requirements for demonstrating therapeutic equivalence for nasal products
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/220888/2026
Summary:
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (876.11 KB - PDF)
Ippubblikat għall-ewwel darba:
Draft guideline on the clinical requirements for medicines intended for the treatment of sickle cell disease
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CHMP/HAEMWP/351950/2024
Summary:
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (362.77 KB - PDF)
Ippubblikat għall-ewwel darba:
Draft guideline on the clinical requirements for medicines intended for the treatment of thalassaemia
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CHMP/HAEMWP/57392/2025
Summary:
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (431.62 KB - PDF)
Ippubblikat għall-ewwel darba:
Draft guideline on user safety for pharmaceutical veterinary medicinal products - Revision 2
Draft: consultation open
Consultation dates:
to
Reference Number: EMEA/CVMP/543/03 Rev.2
Summary:
This revision replaces the previous version of the CVMP guideline on user safety for pharmaceutical veterinary medicinal products (EMEA/CVMP/543/03-Rev.1).
Comments should be provided using the template for comments.
English (EN) (450.28 KB - PDF)
Ippubblikat għall-ewwel darba:
Draft guideline on veterinary good pharmacovigilance practices (VGVP) Module: Signal Management - Revision 1
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/522332/2021 Rev.1
Summary:
This guideline has been revised to reflect the current approach to the signal management process. The guideline provides general guidance on scientific and quality aspects of signal management for veterinary medicinal products (VMPs), and describes the roles, responsibilities and procedural aspects of the EU signal management process for VMPs.
Comments should be provided using this template. The completed comments form should be sent to vet-guidelines@ema.europa.eu
English (EN) (1.28 MB - PDF)
Ippubblikat għall-ewwel darba:
Draft reflection paper on the clinical investigation of medicinal products for the treatment of systemic sclerosis
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/194597/2026
Summary:
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (446.96 KB - PDF)
Ippubblikat għall-ewwel darba:
Concept paper on the revision of the CVMP guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances (EMA/CVMP/383441/2005-Rev.1 Corr.1)
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CVMP/AWP/381531/2025
Summary:
Comments should be provided using this template. The completed comments form should be sent to awpsecretariat@ema.europa.eu
English (EN) (201.29 KB - PDF)
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