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

08/01/2025 - Draft concept paper for the development of a guideline on quality aspects of mRNA vaccines for veterinary use

Draft concept paper for the development of a guideline on quality aspects of mRNA vaccines for veterinary use

Consultation dates: 08/01/2025 to 08/04/2025Draft: consultation openReference Number: EMA/CVMP/IWP/189026/2024 Summary:

This concept paper addresses the need to establish a Guideline on the quality aspects of mRNA vaccines. In the area of human medicinal products, the number applications for clinical trials and marketing authorisations for mRNA containing products significantly increased over the last few years and a lot of experience with mRNA vaccines was gained during the COVID-19 pandemic. It is expected that such developments will be seen in the field of vaccines for veterinary use, too.

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

16/12/2024 - European Union herbal monograph on Species pectorales - draft

European Union herbal monograph on Species pectorales - draft

Consultation dates: 15/12/2024 to 15/03/2025Draft: consultation openReference Number: EMA/HMPC/239465/2024

16/12/2024 - List of references supporting the assessment of Species pectorales - draft

List of references supporting the assessment of Species pectorales - draft

Consultation dates: 15/12/2024 to 15/03/2025Draft: consultation openReference Number: EMA/HMPC/462140/2024

16/12/2024 - Assessment report on Species pectorales - draft

Assessment report on Species pectorales - draft

Consultation dates: 15/12/2024 to 15/03/2025Draft: consultation openReference Number: EMA/HMPC/189454/2023

16/12/2024 - Draft guideline on VICH GL8(R) Stability testing for medicated premixes

Draft guideline on VICH GL8(R) Stability testing for medicated premixes

Consultation dates: 06/12/2024 to 31/05/2025Draft: consultation openReference Number: EMA/CVMP/VICH/836/1999

13/12/2024 - Concept paper for the revision of the Guideline on the requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs)

Concept paper for the revision of the Guideline on the requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs)

Consultation dates: 13/12/2024 to 13/03/2025Draft: consultation openReference Number: EMA/CVMP/IWP/188413/2024

06/12/2024 - Draft qualification opinion for artificial intelligence-based measurement of non-alcoholic steatohepatitis histology in liver biopsies to determine disease activity in NASH/MASH clinical trials

Draft qualification opinion for artificial intelligence-based measurement of non-alcoholic steatohepatitis histology in liver biopsies to determine disease activity in NASH/MASH clinical trials

Consultation dates: 06/12/2024 to 24/01/2025Draft: consultation openReference Number: EMADOC-1700519818-1761332Summary:

Comments should be provided using the template 'Questions and answers: Qualification of digital technology-based methodologies to support approval of medicinal products'. You can find the template here: CHMP qualification opinions

The completed comments form should be sent to [e-mail]

05/12/2024 - Guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration (SCIg/IMIg)

Guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration (SCIg/IMIg)

Consultation dates: 05/12/2024 to 31/05/2025Draft: consultation openReference Number: EMA/CHMP/BPWP/143744/2011 rev.2

05/12/2024 - Draft guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Revision 2

Draft guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Revision 2

Consultation dates: 05/12/2024 to 31/05/2025Draft: consultation openReference Number: EMA/CHMP/BPWP/496692/2023 rev 2Summary:

This guideline replaces guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Revision 1.

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

03/12/2024 - Concept paper on the need for revision of the addendum on weight control in children to the guideline on clinical evaluation of medicinal products used in weight control

Concept paper on the need for revision of the addendum on weight control in children to the guideline on clinical evaluation of medicinal products used in weight control

Consultation dates: 02/12/2024 to 28/02/2025Draft: consultation openReference Number: EMA/501950/2024Summary:

The proposed guideline will replace Guideline on clinical evaluation of medicinal products used in weight control - Addendum on weight control in children (EMEA/CHMP/EWP/517497/2007).

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

29/11/2024 - Draft of Data Quality Framework for EU medicines regulation application to real-world data

Draft of Data Quality Framework for EU medicines regulation application to real-world data

Consultation dates: 29/11/2024 to 28/02/2025Draft: consultation openSummary:

This document describes the Real-World Data (RWD) specific recommendations as derived from the Data Quality Framework (DQF) for EU Medicines regulation endorsed by the Committee for Medicinal Products for Human Use (CHMP). It sets out the principles, concepts, and definitions as intended to be applied widely across datasets used in medicine regulatory use cases. It also provides examples and in-depth clarifications on the developed framework elements for characterising, assessing, and assuring data quality in the regulatory context. Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

29/11/2024 - Draft ICH E6(R3) guideline for good clinical practice – Annex 2 - Step 2b

Draft ICH E6(R3) guideline for good clinical practice – Annex 2 - Step 2b

Consultation dates: 29/11/2024 to 28/02/2025Draft: consultation openReference Number: EMA/CHMP/ICH/495903/2024Summary:

This draft has been adopted by EMA’s human medicines committee (CHMP) and is now open for public consultation. All stakeholders are therefore encouraged to provide their feedback through the dedicated comment template no later than 28 February 2025 to [e-mail] .

29/11/2024 - Draft ICH M15 Guideline on general principles for model-informed drug development - Step 2b

Draft ICH M15 Guideline on general principles for model-informed drug development - Step 2b

Consultation dates: 29/11/2024 to 28/02/2025Draft: consultation openReference Number: EMA/CHMP/ICH/496426/2024Summary:

This guideline defines an harmonised framework for evaluating MIDD evidence and provides recommendations for related planning and regulatory interactions, implementation, reporting, and submission.

In the rapidly evolving landscape of drug development, model-informed drug development (MIDD) evidence is playing an increasingly crucial role in guiding decisions made by drug developers, regulatory authorities, and other key stakeholders.

To streamline the assessment of this valuable evidence, a new guideline has been introduced to facilitate a comprehensive, multidisciplinary approach. 

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

31/10/2024 - Guideline on clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease of the lower extremities

Guideline on clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease of the lower extremities

Consultation dates: 31/10/2024 to 30/04/2025Draft: consultation openReference Number: EMA/CHMP/464798/2024 Rev. 2 (previously EMA/CHMP/464798/2024 Rev. 1)Summary:

This guideline replaces Note for Guidance on clinical investigation of medicinal products for the 10 treatment of peripheral arterial occlusive disease (CPMP/EWP/714/98 rev 1).

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

18/10/2024 - Draft guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances - Revision 1 (second version)

Draft guideline for the demonstration of efficacy for veterinary medicinal products containing anticoccidial substances - Revision 1 (second version)

Consultation dates: 18/10/2024 to 28/02/2025Draft: consultation openReference Number: EMA/CVMP/EWP/755916/2016Summary:

This guideline will replace the current Guideline on anticoccidials used for the therapy of coccidiosis in8
chickens, turkeys and geese (7AE15a).

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

11/10/2024 - Concept paper on clinical evaluation of therapeutic radiopharmaceuticals in oncology

Concept paper on clinical evaluation of therapeutic radiopharmaceuticals in oncology

Consultation dates: 11/10/2024 to 31/01/2025Draft: consultation openReference Number: EMA/CHMP/451705/2024Summary:

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

01/10/2024 - Draft guideline on risk management requirements for elemental impurities in veterinary medicinal products - Revision 3

Draft guideline on risk management requirements for elemental impurities in veterinary medicinal products - Revision 3

Consultation dates: 01/10/2024 to 31/01/2025Draft: consultation openReference Number: EMA/CVMP/426245/2023Summary:

This guideline replaces the Reflection paper on risk management requirements for elemental impurities in veterinary medicinal products, EMA/CVMP/QWP/153641/2018 and the Implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products, EMA/CVMP/QWP/631010/2017-Rev.2.

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

09/09/2024 - Draft guideline on clinical development of medicinal products for the treatment and prevention of bipolar disorder - Revision 1

Draft guideline on clinical development of medicinal products for the treatment and prevention of bipolar disorder - Revision 1

Consultation dates: 09/09/2024 to 31/03/2025Draft: consultation openReference Number: EMA/CHMP/406037/2024 Rev. 1Summary:

This guideline replaces Guideline on clinical investigation of medicinal products in the treatment and prevention of bipolar disorder (CPMP/EWP/567/98). 

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

25/07/2024 - Concept paper for the development of a guideline on the demonstration of therapeutic equivalence for nasal products

Concept paper for the development of a guideline on the demonstration of therapeutic equivalence for nasal products

Consultation dates: 25/07/2024 to 31/01/2025Draft: consultation openReference Number: EMA/CHMP/315603/2024Summary:

The aim of this new guideline is to detail the data requirements for demonstrating therapeutic equivalence between nasal products containing the same active moiety (ies), as these are currently insufficiently covered in existing guidelines.

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

25/07/2024 - Draft guideline on the chemistry of active substances - Revision 1

Draft guideline on the chemistry of active substances - Revision 1

Consultation dates: 25/07/2024 to 31/01/2025Draft: consultation openReference Number: EMA/321776/2024Summary:

Guideline concerning the application of Directive 2001/83/EC with a view to the granting of a marketing authorisation for a medicinal product. This guideline replaces the ‘Note for guidance on chemistry of new active substances’ (CPMP/QWP/130/96, Rev 1) and ‘Chemistry of active substances’ (3AQ5a). It has been revised to cover new and existing active substances in one guideline.

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

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