Open consultations
The list below includes the European Medicines Agency's (EMA) open public consultations.
Human
Veterinary
Scientific 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 KB - DOC)
First published:
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:
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:
Open consultations
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 KB - PDF)
First published:
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 KB - PDF)
First published:
Concept paper on new guidance on the clinical investigation of medicinal products for the treatment of idiopathic pulmonary fibrosis (IPF)
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CHMP/290364/2025
Summary:
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (221.15 KB - PDF)
First published:
Reflection paper on patient experience data
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CHMP/PRAC/148869/2025
Summary:
Comments should be provided using this form. The completed comments form should be sent to PED_RP@ema.europa.eu
English (EN) (544.8 KB - PDF)
First published:
Eltrombopag film-coated tablets 12.5 mg, 25 mg, 50 mg, 75 mg and powder for oral suspension 25 mg product-specific bioequivalence guidance
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/226445/2025
Summary:
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (154.58 KB - PDF)
First published:
Melatonin prolonged release tablets 2 mg product-specific bioequivalence guidance
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/226444/2025
Summary:
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (155.49 KB - PDF)
First published:
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 KB - PDF)
First published:
ICH Q3E Guideline for extractables and leachables - supporting documentation: class 3 leachable monographs
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CHMP/ICH/236668/2025
Summary:
Comments should be provided using this template. The completed comments form should be sent to ich@ema.europa.eu
English (EN) (1.4 MB - PDF)
First published:
ICH Q3E Guideline for extractables and leachables
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CHMP/ICH/236669/2025
Summary:
Comments should be provided using this template. The completed comments form should be sent to ich@ema.europa.eu
English (EN) (1.37 MB - PDF)
First published:
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 KB - PDF)
First published:
Draft European Union herbal monograph on Species diureticae - Revision 1
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/HMPC/85836/2025
Summary:
Email address for submissions: hmpc.secretariat@ema.europa.eu
English (EN) (285.96 KB - PDF)
First published:
Draft European Union herbal monograph on Fragaria vesca L.; Fragaria moschata Weston; Fragaria viridis Weston; Fragaria x ananassa (Weston) Duchesne ex Rozier, folium - Revision 1
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/HMPC/10134/2024
Summary:
Email address for submissions: hmpc.secretariat@ema.europa.eu
English (EN) (243.52 KB - PDF)
First published:
Draft European Union herbal monograph on Glycyrrhiza glabra L.; Gycyrrhiza inflata Bat.; Glycyrrhiza uralensis Fisch., radix – Revision 1
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/HMPC/108399/2024
Summary:
Email address for submissions: hmpc.secretariat@ema.europa.eu
English (EN) (289.67 KB - PDF)
First published:
Draft public statement on Cannabis sativa L., flos
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/HMPC/69833/2025
Summary:
Email address for submissions: hmpc.secretariat@ema.europa.eu
English (EN) (138.1 KB - PDF)
First published:
Draft concept paper on the development of a reflection paper on the use of external controls for evidence generation in regulatory decision-making
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CHMP/225255/2025
Summary:
Randomised controlled trials are the gold standard of evidence to support causal conclusions on the benefits and risks of medicines in regulatory decision making along the lifecycle.
However, in some situations, causal conclusions may be derived from a setting where the investigational medicinal product data was collected under a clinical trial protocol while the control arm was not a randomized arm in that same protocol. In these situations, a so-called external control, may be derived from data from other clinical trials, real-world data (RWD) or other data sources.
A reflection paper shall be drafted to describe the main challenges with external controls and further discuss the circumstances and methodological constraints under which the use of external controls could be considered appropriate for generating pivotal or supportive evidence, either for efficacy, safety or other relevant regulatory decision-making objectives.
This concept paper outlines the scope and content of the reflection paper.
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support .
English (EN) (157.56 KB - PDF)
First published:
Dronedarone film-coated tablets 400 mg product-specific bioequivalence guidance - Revision 1
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/151695/2025 Rev. 1
English (EN) (158.79 KB - PDF)
First published:
Ledipasvir/sofosbuvir film-coated tablet 45 mg/200 mg and 90 mg/400 mg, coated granules 33.75mg/150mg and 45mg/200mg product-specific bioequivalence guidance - Revision 1
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/151702/2025 Rev. 1
English (EN) (175.98 KB - PDF)
First published:
Aliskiren film-coated tablet 150 mg and 300 mg product-specific bioequivalence guidance - Revision 1
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/151687/2025 Rev. 1
English (EN) (185.42 KB - PDF)
First published:
Sirolimus coated tablets 0.5, 1 and 2 mg, oral solution 1 mg/ml product-specific bioequivalence guidance - Revision 1
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/151700/2025 Rev. 1*
English (EN) (173.8 KB - PDF)
First published:
ICH E20 guideline on adaptive designs for clinical trials - Step 2b
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CHMP/ICH/206586/2025
Summary:
This document provides guidance on confirmatory clinical trials planned with an adaptive design within the context of its overall development programme, allowing pre-specified modifications of the trial design based on an interim analysis of the on-going trial.
Comments should be provided using this template. The completed comments form should be sent to ich@ema.europa.eu
English (EN) (904.75 KB - PDF)
First published: