Open consultations
The list below includes the European Medicines Agency's (EMA) open public consultations.
HumanVeterinaryScientific guidelines
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:
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:
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:
Open consultations
ICH M11 Technical Specification - Updated step 2b
Draft: consultation openConsultation dates:
to Reference Number: EMA/CHMP/ICH/778800/2022Summary:
Rationale for a second public consultation on the Technical Specification:
The ICH M11 EWG has now completed the TS, incorporating the refinements needed to ensure its alignment with the updated template. This updated version of the template reflects public feedback from the 2022 consultation and additional input from the EWG’s ongoing work. A second public consultation on the TS is being conducted to provide the public with an opportunity to review and comment on the updated version.
Role of the M11 Protocol Template in supporting the second public consultation on the Technical Specification:
To assist with the review and public comment on the completed TS, the updated template is being provided as a reference document. It is important to emphasise that the purpose of this consultation is to seek public comment on the TS alone. The template is included solely to aid in the review and understanding of the TS and is not open for public comment during this consultation, as it was thoroughly reviewed during the 2022 public consultation period.
Comments should be provided using this template. The completed comments form should be sent to ich@ema.europa.eu
English (EN) (1.75 MB - PDF)
First published:
Call for scientific data for the periodic review of the monograph on Passiflorae herba
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/64557/2025
English (EN) (128.46 KB - PDF)
First published:
Call for scientific data for the periodic review of the monograph on Hederae helicis folium
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/64513/2025
English (EN) (128.02 KB - PDF)
First published:
Call for scientific data for the periodic review of the monograph on Eleutherococci radix
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/64400/2025
English (EN) (129.24 KB - PDF)
First published:
Call for scientific data for the periodic review of the monograph on Betulae folium
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/64356/2025
English (EN) (129.34 KB - PDF)
First published:
Call for scientific data for the periodic review of the monograph on Primulae radix
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/64684/2025
English (EN) (129.37 KB - PDF)
First published:
Call for scientific data for the periodic review of the monograph on Primulae flos
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/64619/2025
English (EN) (129.32 KB - PDF)
First published:
Draft guideline on the clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome - Revision 2
Draft: consultation openConsultation dates:
to Reference Number: EMA/67201/2025Summary:
This guideline replaces the guideline on clinical investigation of medicinal products for the treatment of patients with acute respiratory distress syndrome (EMEA/CPMP/EWP/504/97 Rev.1).
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (453.45 KB - PDF)
First published:
Draft European Union herbal monograph on Hypericum perforatum L, herba and Cimicifuga racemosa (L.) Nutt., rhizoma
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/884573/2022
English (EN) (341.96 KB - PDF)
First published:
Call for scientific data for the periodic review of the monograph on Valerianae radix
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/42303/2025
English (EN) (128.8 KB - PDF)
First published:
Call for scientific data for the periodic review of the monograph on Valerianae aetheroleum
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/42266/2025
English (EN) (128.72 KB - PDF)
First published:
Call for scientific data for the periodic review of the monograph on Salviae officinalis folium
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/42211/2025
English (EN) (120.59 KB - PDF)
First published:
Call for scientific data for the periodic review of the monograph on Centaurii herba
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/41748/2025
English (EN) (122.67 KB - PDF)
First published:
Call for scientific data for the periodic review of the monograph on Anisi fructus
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/41594/2025
English (EN) (121.13 KB - PDF)
First published:
Call for scientific data for the periodic review of the monograph on Anisi aetheroleum
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/41176/2025
English (EN) (120.81 KB - PDF)
First published:
Concept paper on the development of a Guideline on assessment and reporting of mechanistic models used in the context of model informed drug development
Draft: consultation openConsultation dates:
to Reference Number: EMA/5875/2025
English (EN) (187.72 KB - PDF)
First published:
Draft reflection paper on the current regulatory testing requirements for veterinary medicinal products and opportunities for implementation of the 3Rs - Revision 1
Draft: consultation openConsultation dates:
to Reference Number: EMA/CHMP/CVMP/3Rs/164002/2016 Rev. 1
English (EN) (576.14 KB - PDF)
First published:
Draft reflection paper on the current regulatory testing requirements for medicinal products for human use and opportunities for implementation of the 3Rs - Revision 1
Draft: consultation openConsultation dates:
to Reference Number: EMA/CHMP/CVMP/3Rs/742466/2015 Rev. 1
English (EN) (698.16 KB - PDF)
First published:
Draft reflection paper on the use of information in European Union herbal monographs and assessment reports for borderline issues
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/224438/2024Summary:
Comments should be provided using this template to hmpc.secretariat@ema.europa.eu
English (EN) (241.92 KB - PDF)
First published:
Paclitaxel (nanoparticle albumin-bound) powder for suspension for infusion, 5mg/ml
Draft: consultation openConsultation dates:
to Reference Number: EMA/418520/2024Summary:
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (146.49 KB - PDF)
First published: