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

Prikaži

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

Prikaži

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

Prikaži

Draft ‘Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products / traditional herbal medicinal products’ - Revision 2

Draft: consultation open Consultation dates: 01/04/2026 to 30/06/2026 Reference Number: EMA/HMPC/CHMP/CVMP/287539/2005 Rev. 2 Summary:

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

English (EN) (321.99 KB - PDF)

First published: 01/04/2026

Prikaži

Paediatric addendum to CHMP guideline on the clinical investigations of medicinal products for the treatment of pulmonary arterial hypertension

Draft: consultation open Consultation dates: 31/03/2026 to 30/09/2026 Reference Number: EMA/CHMP/60723/2026 Summary:

This document replaces Guideline EMA/CHMP/213972/2010.

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

English (EN) (307 KB - PDF)

First published: 31/03/2026

Prikaži

Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosis

Draft: consultation open Consultation dates: 31/03/2026 to 30/09/2026 Reference Number: EMA/61447/2026 Summary:

The proposed guideline will replace the Guideline on clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosis (ALS) (EMA/531686/2015, Corr.1, 19 November 2015).

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

English (EN) (216.26 KB - PDF)

First published: 31/03/2026

Prikaži

Draft Qualification opinion for Virtual Control Groups (VCG) to replace Concurrent Control Groups (CCG) in rat non-GLP Dose-Range Finding (DRF) studies

Draft: consultation open Consultation dates: 31/03/2026 to 12/05/2026 Reference Number: EMADOC-1700519818-3025927 Summary:

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

English (EN) (2.15 MB - PDF)

First published: 31/03/2026

Prikaži

Call for scientific data for the periodic review of the monograph on Taraxaci radix cum herba

Draft: consultation open Consultation dates: 15/03/2026 to 15/06/2026 Reference Number: EMA/HMPC/57646/2026

English (EN) (121.47 KB - PDF)