Open consultations

The list below includes the European Medicines Agency's (EMA) open public 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

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

Template for submission of comments on ICH guidelines

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

Open consultations

24/10/2025 - Draft qualification opinion for molecule-independent device bridging approach (MIDBA)

Draft qualification opinion for molecule-independent device bridging approach (MIDBA)

Draft: consultation open Consultation dates: 24/10/2025 to 19/12/2025 Reference Number: EMADOC-1700519818-2552151 Summary:

Comments should be provided using this template. The completed comments form should be sent to [e-mail] 

24/10/2025 - Draft guideline on quality aspects of phage therapy medicinal products

Draft guideline on quality aspects of phage therapy medicinal products

Draft: consultation open Consultation dates: 23/10/2025 to 30/04/2026 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.

23/10/2025 - Reflection paper on non-human primates in safety testing of human medicinal products and opportunities for 3Rs implementation

Reflection paper on non-human primates in safety testing of human medicinal products and opportunities for 3Rs implementation

Draft: consultation open Consultation dates: 23/10/2025 to 31/01/2026 Reference Number: EMA/CHMP/55697/2025 Summary:

This reflection paper aims to provide an overview of the scientific and regulatory considerations for non human primate use in safety testing of human medicinal products. It highlights the existing flexibility within published guidelines to incorporate 3Rs approaches and describes novel alternative approaches which may become available in the future.  Notwithstanding the detailed conditions outlined herein, some important examples include; use of rodent species (including transgenics) only to evaluate repeat dose toxicity, the waiving of long-term (6 month) studies to evaluate the safety risk associated with monoclonal antibodies, the use of alternative assays to predict malformations or embryo-foetal lethality in developmental and reproductive toxicity.

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

22/10/2025 - Concept paper on a paediatric update of the Guideline on clinical investigation of medicinal products for the management of Crohn’s disease

Concept paper on a paediatric update of the Guideline on clinical investigation of medicinal products for the management of Crohn’s disease

Draft: consultation open Consultation dates: 22/10/2025 to 31/12/2025 Reference Number: EMA/CHMP/312837/2025 Summary:

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

22/10/2025 - Concept paper on a paediatric update on the Guideline on the development of new medicinal products for the treatment of Ulcerative Colitis

Concept paper on a paediatric update on the Guideline on the development of new medicinal products for the treatment of Ulcerative Colitis

Draft: consultation open Consultation dates: 31/10/2025 to 31/12/2025 Reference Number: EMA/CHMP/312843/2025 Summary:

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

15/10/2025 - Draft list of references supporting the assessment of Zea mays, L., stigma

Draft list of references supporting the assessment of Zea mays, L., stigma

Draft: consultation open Consultation dates: 15/10/2025 to 15/01/2026 Reference Number: EMA/HMPC/509422/2023

15/10/2025 - Draft assessment report on Zea mays L., stigma

Draft assessment report on Zea mays L., stigma

Draft: consultation open Consultation dates: 15/10/2025 to 15/01/2026 Reference Number: EMA/HMPC/509423/2023

15/10/2025 - Draft European Union herbal monograph on Zea mays L., stigma

Draft European Union herbal monograph on Zea mays L., stigma

Draft: consultation open Consultation dates: 15/10/2025 to 15/01/2026 Reference Number: EMA/HMPC/509424/2023

30/09/2025 - Draft guideline on the clinical evaluation of medicinal products intended for the treatment of chronic hepatitis B (CHB) - Revision 1

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: 30/09/2025 to 31/03/2026 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.

30/09/2025 - Draft guideline on clinical investigation of medicinal products for the treatment of psoriatic arthritis - Revision 1

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

Draft: consultation open Consultation dates: 30/09/2025 to 31/03/2026 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.

30/09/2025 - Concept paper on new guidance on the clinical investigation of medicinal products for the treatment of idiopathic pulmonary fibrosis (IPF)

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: 30/09/2025 to 31/12/2025 Reference Number: EMA/CHMP/290364/2025 Summary:

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

29/09/2025 - Reflection paper on patient experience data

Reflection paper on patient experience data

Draft: consultation open Consultation dates: 29/09/2025 to 31/01/2026 Reference Number: EMA/CHMP/PRAC/148869/2025 Summary:

Comments should be provided using this form. The completed comments form should be sent to [e-mail]

25/09/2025 - Eltrombopag film-coated tablets 12.5 mg, 25 mg, 50 mg, 75 mg and powder for oral suspension 25 mg product-specific bioequivalence guidance

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: 25/09/2025 to 31/12/2025 Reference Number: EMA/226445/2025 Summary:

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

25/09/2025 - Melatonin prolonged release tablets 2 mg product-specific bioequivalence guidance

Melatonin prolonged release tablets 2 mg product-specific bioequivalence guidance

Draft: consultation open Consultation dates: 25/09/2025 to 31/12/2025 Reference Number: EMA/226444/2025 Summary:

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

15/09/2025 - VICH GL62 on target animal safety of veterinary monoclonal antibody products (VMAPs)

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

Draft: consultation open Consultation dates: 15/09/2025 to 15/02/2026 Reference Number: EMA/CVMP/VICH/250843/2021 Summary:

Comments should be provided using this template. The completed comments form should be sent to [e-mail]

18/08/2025 - ICH Q3E Guideline for extractables and leachables - supporting documentation: class 3 leachable monographs

ICH Q3E Guideline for extractables and leachables - supporting documentation: class 3 leachable monographs

Draft: consultation open Consultation dates: 18/08/2025 to 18/12/2025 Reference Number: EMA/CHMP/ICH/236668/2025 Summary:

Comments should be provided using this template. The completed comments form should be sent to [e-mail] 

18/08/2025 - ICH Q3E Guideline for extractables and leachables

ICH Q3E Guideline for extractables and leachables

Draft: consultation open Consultation dates: 18/08/2025 to 18/12/2025 Reference Number: EMA/CHMP/ICH/236669/2025 Summary:

Comments should be provided using this template. The completed comments form should be sent to [e-mail] 

 

 

06/08/2025 - Concept paper on the need for revision of the guideline on the clinical investigation of medicines for the treatment of Alzheimer's disease

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: 06/08/2025 to 28/02/2026 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.

30/06/2025 - ICH E20 guideline on adaptive designs for clinical trials - Step 2b

ICH E20 guideline on adaptive designs for clinical trials - Step 2b

Draft: consultation open Consultation dates: 30/06/2025 to 30/11/2025 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 [e-mail]