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 Guideline M13B on bioequivalence for immediate release solid oral dosage forms - additional strengths - Step 2b
Draft: consultation openConsultation dates:
to Reference Number: EMA/CHMP/ICH/85092/2025Summary:
This guideline is intended to provide recommendations on obtaining waivers of bioequivalence (BE) studies for one or more additional strengths of a drug product in an application where in vivo BE has been demonstrated for at least one of the strengths. The guideline is applicable during both development and post-approval phases of orally administered immediate release (IR) solid dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension.
Comments should be provided using this template. The completed comments form should be sent to ich@ema.europa.eu
English (EN) (1.66 MB - PDF)
First published:
Reflection paper on a tailored clinical approach in biosimilar development
Draft: consultation openConsultation dates:
to Reference Number: EMA/CHMP/BMWP/60916/2025
English (EN) (344.69 KB - PDF)
First published:
Call for scientific data for the periodic review of the monograph on Valerianae radix and Lupuli flos
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/110690/2025
English (EN) (119.42 KB - PDF)
First published:
Call for scientific data for the periodic review of the monograph on Salicis cortex
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/95838/2025
English (EN) (119.67 KB - PDF)
First published:
Call for scientific data for the periodic review of the monograph on Psyllii semen
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/95545/2025
English (EN) (118.4 KB - PDF)
First published:
Call for scientific data for the periodic review of the monograph on Harpagophyti radix
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/95238/2025
English (EN) (119.87 KB - PDF)
First published:
Call for scientific data for the periodic review of the monograph on Hamamelidis folium et cortex aut ramunculus destillatum
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/110527/2025
English (EN) (118.78 KB - PDF)
First published:
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:
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:
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) (499.57 KB - PDF)
First published: Last updated:
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) (408.41 KB - PDF)
First published: Last updated: