Open consultations

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HumanVeterinaryHerbalScientific guidelines

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Use the dedicated EUSurvey link or consultation template in the relevant consultation document to submit your comments.

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Templates

Download the standard consultation template below. You can also find them in the relevant consultation document.

Template for submission of comments on scientific guidelines

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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

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Open consultations

Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files - Revision 1

Draft: consultation open Consultation dates: to Reference Number: EMA/INS/PhV/68655/2026 Summary:

The Guideline on veterinary good pharmacovigilance practices (VGVP) – Module on Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files was adopted in November 2021 and came into effect on 28 January 2022. Revision 1 of the guideline is based on the experience of pharmacovigilance inspectors, common inspection findings, and questions and requests for clarification received from marketing authorisation holders. The proposed changes affect:

  • Section 1 – Introduction
  • Section 2 – Pharmacovigilance
  • Section 2.1 – Qualified person responsible for pharmacovigilance
  • Section 2.2.2 – Performance indicators
  • Section 2.2.3 – Audits
  • Section 2.2.7 – Quality management system requirements for pharmacovigilance tasks contracted or subcontracted by the marketing authorisation holder

In addition, an appendix has been added to provide further guidance on the content of the pharmacovigilance system master file (PSMF), particularly the annexes. This reflects experience gained from pharmacovigilance inspections and addresses requests from marketing authorisation holders for more guidance on the information to include in each annex. No concept paper was prepared for this revision, as it does not constitute either a new guideline or a significant revision of the existing guideline. The scope of the public consultation is limited to the proposed changes, which are provided in track changes to facilitate review. Comments should be submitted using the dedicated template. The completed comments form should be sent to phvins@ema.europa.eu, with Vet-Guidelines@ema.europa.eu copied (in cc:).

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Concept paper on the quality and safety aspects of RNA interference and RNA antisense oligonucleotide therapies as veterinary medicinal products

Draft: consultation open Consultation dates: to Reference Number: EMA/CVMP/NTWP/24800/2026 Summary:

This concept paper addresses the need for a guideline on the quality and safety aspects of RNA interference and RNA antisense oligonucleotide therapies as veterinary medicinal products.

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

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Concept paper on the revision of the guideline on pharmaceutical fixed combination products (EMA/CVMP/83804/2005-Rev.1)

Draft: consultation open Consultation dates: to Reference Number: EMA/CVMP/EWP/54206/2026 Summary:

The CVMP guideline on pharmaceutical fixed combination products (EMA/CVMP/83804/2005) was initially adopted in December 2006. The last revision (Rev.1) was carried out in July 2021, with the purpose to implement administrative changes to update the guideline with the new definitions and terminology provided by Article 4 of Regulation (EU) 2019/6.
This concept paper addresses the need for a more thorough revision of the guideline, in line with Regulation (EU) 2019/6, the European Commission’s Guidance to Applicants (C/2024/1443) and the CVMP guideline on the evaluation of the benefit-risk balance of veterinary medicinal products (EMA/CVMP/248499/2007-Rev.1). It also takes into consideration the experience gained in the assessment of data for fixed combination veterinary medicinal products. This experience has highlighted the need for further clarification and updating of certain aspects of the guideline to ensure alignment with current scientific knowledge and regulatory requirements.

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

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Concept paper on revision of: Guideline on similar biological medicinal products, CHMP/437/04 Rev.1

Draft: consultation open Consultation dates: to Reference Number: EMA/CHMP/BMWP/153523/2026 Summary:

The proposed guideline will replace: Guideline on similar biological medicinal products (CHMP/437/04 Rev.1).

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

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Draft reflection paper on particulars for safety signals for (traditional) herbal medicinal products

Draft: consultation open Consultation dates: to Reference Number: EMA/HMPC/PRAC/301178/2025 Summary:

Comments should be provided using this template to hmpc.secretariat@ema.europa.eu 

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Semaglutide and FlexTouch solution for injection in pre-filled pen product-specific bioequivalence guidance - various strengths

Draft: consultation open Consultation dates: to Reference Number: EMA/106257/2026 Summary:

The guidance covers the following products:

  • Semaglutide, 0.25, 0.5, 1 and 2 mg solution for injection in pre-filled pen, 0.25, 0.5, 1, 1.7 and 2.4 mg solution for injection in pre-filled pen
  • FlexTouch, 0.25, 0.5, 1, 1.7 and 2.4 mg solution for injection in pre-filled pen

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

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Concept paper on the revision of the guideline on the clinical evaluation of antifungal agents for the treatment and prophylaxis of invasive fungal disease

Draft: consultation open Consultation dates: to Reference Number: EMA/133954/2026 Summary:

The proposed guideline will replace guideline on the clinical evaluation of antifungal agents intended for the treatment and prophylaxis of invasive fungal diseases (CHMP/EWP/1343/01 Rev. 1).

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

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Concept paper on the revision of the guideline on data requirements for authorisation of immunological veterinary medicinal products in exceptional circumstances (EMA/CVMP/IWP/251947/2021)

Draft: consultation open Consultation dates: to Reference Number: EMA/CVMP/IWP/385629/2025 Summary:

The “Guideline on data requirements for authorisation of immunological veterinary medicinal products in exceptional circumstances” was adopted on 19 January 2022 and came into effect on 28 January 2022. This document was intended to provide advice to manufacturers seeking marketing authorisation  in exceptional circumstances related to animal or public health included in Articles 25, 26 and 27 of Regulation (EU) 2019/6, based on a reduced data set regarding quality, safety and efficacy and the benefit of the immediate availability on the market to the animal or public health outweighs the risks arising from the fact that some data are not available. Based on experience with the first marketing authorisation applications submitted under Art. 25, it has become evident that several sections of the guideline require further detail and clarification to ensure consistent interpretation.

Further clarification to ensure consistent understanding and application of the requirements is necessary. Additionally, some relevant references to legal texts and guidance documents should be included.

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

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Concept paper on the revision of the guideline on data requirements for the replacement of established master seeds (MS) already used in authorised immunological veterinary medicinal products (IVMPs) by new MS of the same origin

Draft: consultation open Consultation dates: to Reference Number: EMA/CVMP/IWP/385637/2025 Summary:

The proposed guideline will replace the “Guideline on data requirements for the replacement of established master seeds (MS) already used in authorised immunological veterinary medicinal products (IVMPs) by new master seed of the same origin“ (EMEA/CVMP/IWP/105504/2007) and the “Reflection paper on the replacement of cell lines used for the production of immunological veterinary medicinal products” (EMA/CVMP/IWP/37620/2014).

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

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Guideline on the clinical evaluation of medicinal products for weight management - Addendum on weight control in children

Draft: consultation open Consultation dates: to Reference Number: EMA/126591/2026 Summary:

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

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

Draft: consultation open Consultation dates: to Reference Number: EMA/HMPC/216490/2025 Summary:

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

English (EN) (240.34 KB - PDF)

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

Draft: consultation open Consultation dates: to Reference Number: EMA/HMPC/216488/2025 Summary:

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

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

Draft: consultation open Consultation dates: to Reference Number: EMA/HMPC/216489/2025 Summary:

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

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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: to 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.

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

Draft: consultation open Consultation dates: to Reference Number: EMA/85747/2026 Summary:

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

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

Draft: consultation open Consultation dates: to Reference Number: EMA/65789/2026 Summary:

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

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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: to 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 

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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: to 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.

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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: to 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.

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Draft guideline on the clinical investigation of medicinal products for the treatment of cystic fibrosis

Draft: consultation open Consultation dates: to Reference Number: EMA/21378/2026 Summary:

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

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