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
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:
Aprepitant, hard capsules, 80mg, 125mg, 80+125mg and powder for oral suspension 125mg product-specific bioequivalence guidance
Draft: consultation openConsultation dates:
to Reference Number: EMA/13174/2025Summary:
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (145.79 KB - PDF)
First published:
Draft reflection paper on the qualification of non-mutagenic impurities
Draft: consultation openConsultation dates:
to Reference Number: EMA/CHMP/543397/2024Summary:
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (721.42 KB - PDF)
First published:
Draft guideline on VICH GL8(R) Stability testing for medicated premixes
Draft: consultation openConsultation dates:
to Reference Number: EMA/CVMP/VICH/836/1999
English (EN) (249.19 KB - PDF)
First published:
Guideline on core SmPC for human normal immunoglobulin for subcutaneous and intramuscular administration (SCIg/IMIg)
Draft: consultation openConsultation dates:
to Reference Number: EMA/CHMP/BPWP/143744/2011 rev.2
English (EN) (499.68 KB - PDF)
First published:
Draft guideline on the clinical investigation of human normal immunoglobulin for subcutaneous and/or intramuscular administration (SCIg/IMIg) - Revision 2
Draft: consultation openConsultation dates:
to Reference 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.
English (EN) (416.81 KB - PDF)
First published:
Draft guideline on clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease of the lower extremities - Revision 2
Draft: consultation openConsultation dates:
to Reference 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.
English (EN) (377.54 KB - PDF)
First published: