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 Hamamelidis folium
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/110502/2025
English (EN) (118.12 KB - PDF)
First published:
Call for scientific data for the periodic review of the monograph on Hamamelidis cortex
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/110242/2025
English (EN) (118.57 KB - PDF)
First published:
Call for scientific data for the periodic review of the monograph on Equiseti herba
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/93113/2025
English (EN) (118.37 KB - PDF)
First published:
Call for scientific data for the periodic review of the monograph on Carvi fructus
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/110965/2025
English (EN) (117.53 KB - PDF)
First published:
Call for scientific data for the periodic review of the monograph on Carvi aetheroleum
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/110735/2025
English (EN) (117.62 KB - PDF)
First published:
Call for scientific data for the periodic review of the monograph on Althaeae radix
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/92238/2025
English (EN) (118.11 KB - PDF)
First published:
Concept paper on the revision of the guideline on the Scientific Data Requirements for a Plasma Master File (PMF) Revision 1 and Annexes
Draft: consultation openConsultation dates:
to Reference Number: EMA/CHMP/BWP/91140/2025Summary:
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (178.58 KB - PDF)
First published:
Draft guideline on the quality aspects of mRNA vaccines
Draft: consultation openConsultation dates:
to Reference Number: EMA/CHMP/BWP/82416/2025Summary:
This guideline addresses the quality aspects of mRNA vaccines. It addresses specific aspects regarding the manufacturing process, characterisation, specifications and analytical control of mRNA vaccines, as well as the definition of starting materials, active substance and finished product for mRNA vaccines. Additional regulatory considerations are provided for changes in existing mRNA vaccine strains, bivalent and multivalent vaccines, self-amplifying mRNA vaccines, other delivery systems and use of platform technology/prior knowledge. The scope of this guideline is applicable to mRNA vaccines against infectious diseases. Other mRNA-based medicinal products are out of scope of this guideline, although relevant parts of this guideline may be applicable to those. It is not intended to address specific requirements for mRNA vaccines to be used in clinical trials, however the scientific principles described may also be applicable during pharmaceutical development.
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (378.83 KB - PDF)
First published:
Draft Reflection paper on linking to electronic product information (ePI) from EU medicine packages
Draft: consultation openConsultation dates:
to Reference Number: EMA/95076/2025Summary:
Comments should be provided using the EUSurvey form. For any technical issues with the form, please contact the EUSurvey Support.
English (EN) (351.56 KB - 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: