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)

Публикувано за първи път: 27/01/2023

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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)

Публикувано за първи път: 15/02/2023

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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)

Публикувано за първи път: 14/02/2020

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Draft European Union herbal monograph on Glycine max (L.) Merr., lecithinum

Draft: consultation open Consultation dates: 01/06/2026 to 31/08/2026 Reference Number: EMA/HMPC/216490/2025 Summary:

Email address for submissions: hmpc.secretariat@ema.europa.eu

English (EN) (240.34 KB - PDF)

Публикувано за първи път: 01/06/2026

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Draft assessment report on Glycine max (L.) Merr., lecithinum

Draft: consultation open Consultation dates: 01/06/2026 to 31/08/2026 Reference Number: EMA/HMPC/216488/2025 Summary:

Email address for submissions: hmpc.secretariat@ema.europa.eu

English (EN) (420.29 KB - PDF)

Публикувано за първи път: 01/06/2026

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Draft list of references supporting the assessment of Glycine max (L.) Merr., lecithinum

Draft: consultation open Consultation dates: 01/06/2026 to 31/08/2026 Reference Number: EMA/HMPC/216489/2025 Summary:

Email address for submissions: hmpc.secretariat@ema.europa.eu

English (EN) (145.39 KB - PDF)

Публикувано за първи път: 01/06/2026

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Concept paper on the need for revision of the guideline on the development of medicinal products for the treatment of smoking

Draft: consultation open Consultation dates: 29/05/2026 to 30/08/2026 Reference Number: EMA/112569/2026 Summary:

The scope of the current guideline is to provide guidance in the definition of treatment goals, study design, outcome measures, and data analysis for new medicinal products that will be developed to treat nicotine dependence in support of an indication for the treatment of tobacco smoking.

There has been a rapid development of essentially tobacco-free recreational products containing nicotine for inhalation (e.g. electronic cigarettes) and oromucosal use (e.g. snuff) in the EU. Addiction to tobacco-free nicotine products has become an increasing problem, especially in the adolescent and young adult populations.

The current guideline is not intended for and is neither completely applicable for development of medicinal products for the treatment of the addiction to non-smoking nicotine products. Nevertheless, as no other guideline applies in those cases, the guideline for smoking cessation is still the most relevant. To meet the treatment needs arising from the new types of nicotine addiction, adjustments of this guideline are proposed for the document to be fully applicable for all types of nicotine dependence.

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

English (EN) (162.98 KB - PDF)

Публикувано за първи път: 29/05/2026

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Tafamidis soft gelatin capsules 20 mg and 61 mg product-specific bioequivalence guidance

Draft: consultation open Consultation dates: 30/04/2026 to 31/07/2026 Reference Number: EMA/85747/2026 Summary:

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

English (EN) (148.36 KB - PDF)

Публикувано за първи път: 30/04/2026

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Liraglutide 6 mg/mL solution for injection in a prefilled pen product-specific bioequivalence guidance

Draft: consultation open Consultation dates: 30/04/2026 to 31/07/2026 Reference Number: EMA/65789/2026 Summary:

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

English (EN) (186.44 KB - PDF)

Публикувано за първи път: 30/04/2026

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Annexes to ICH Q3C guideline on impurities: guideline for residual solvents (EMA/CHMP/ICH/82260/2006) and VICH GL18 Impurities: residual solvents in new veterinary medicinal products, active substances and excipients (EMA/CVMP/VICH/502/1999) - Revision 2

Draft: consultation open Consultation dates: 29/04/2026 to 30/06/2026 Reference Number: CPMP/QWP/450/03 Rev.2; EMEA/CVMP/511/03 Rev.2 Summary:

Only Annex I has been updated. Comments are requested on the updates implemented to Annex I and on the helpfulness of the decision trees (new addition). Annex II has not been revised, hence no comments are expected on this section.

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

English (EN) (401.07 KB - PDF)

Публикувано за първи път: 29/04/2026

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Draft concept paper on the development for guidance on demonstration of biosimilarity of biological veterinary medicinal products

Draft: consultation open Consultation dates: 24/04/2026 to 31/07/2026 Reference Number: EMA/CVMP/121133/2025 Summary:

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

English (EN) (217.69 KB - PDF)

Публикувано за първи път: 24/04/2026

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Draft reflection paper on the use of macrolides, lincosamides and streptogramins (MLS) in animals in the European Union: development of resistance and impact on public and animal health - Revision 1

Draft: consultation open Consultation dates: 24/04/2026 to 31/08/2026 Reference Number: EMA/CVMP/AWP/741087/2009 Rev. 1 Summary:

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

English (EN) (1.34 MB - PDF)

Публикувано за първи път: 24/04/2026

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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)

Публикувано за първи път: 01/04/2026

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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)

Публикувано за първи път: 31/03/2026

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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)

Публикувано за първи път: 31/03/2026

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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)