Open consultations
The list below includes the European Medicines Agency's (EMA) open public consultations.
HumanVeterinaryHerbalScientific 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 Herniariae herba
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/HMPC/57022/2026
English (EN) (129.46 KB - PDF)
First published:
Call for scientific data for the periodic review of the monograph on Filipendulae ulmariae herba
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/HMPC/39822/2026
English (EN) (130.23 KB - PDF)
First published:
Call for scientific data for the periodic review of the monograph on Filipendulae ulmariae flos
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/HMPC/37952/2026
English (EN) (130.26 KB - PDF)
First published:
Call for scientific data for the periodic review of the monograph on Chamomillae romanae flos
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/HMPC/37916/2026
English (EN) (130 KB - PDF)
First published:
Call for scientific data for the periodic review of the monograph on Arctii radix
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/HMPC/37510/2026
English (EN) (128.6 KB - PDF)
First published:
Call for scientific data for the periodic review of the monograph on Tormentillae rhizoma
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/HMPC/57656/2026
English (EN) (120.79 KB - PDF)
First published:
Concept paper on the development of a reflection paper on proof-of-concept data to support the development of anti-cancer medicinal products in paediatric patients
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/32831/2026
Summary:
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (172.47 KB - PDF)
First published:
Guideline on the clinical investigation of medicinal products for the treatment of cystic fibrosis
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/21378/2026
Summary:
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (705.63 KB - PDF)
First published:
Draft guideline on quality aspects of mRNA vaccines for veterinary use
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CVMP/IWP/128476/2025
Summary:
The aim of the guideline is to outline the information which should be included for mRNA vaccines in the marketing authorisation application (MAA) dossier of veterinary vaccines as required in Section IIIb of Annex II to Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products (repealing Directive 2001/82/EC), referred to as Annex II to Regulation (EU) 2019/6 throughout the document.
The data requirements and points for consideration for the demonstration of quality of veterinary mRNA vaccines are discussed, and guidance is provided on the information to be included in Part 2 of the MAA dossier.
Comments should be provided using our template. The completed comments form should be sent to vet-guidelines@ema.europa.eu.
English (EN) (179.64 KB - PDF)
First published:
Concept paper on the need of a guideline on clinical investigation of medicinal products in the treatment of Myasthenia Gravis
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/9533/2026
Summary:
Comments should be provided using this EUsurvey form. For any technical issues, please contact the
EUSurvey Support.
English (EN) (191.05 KB - PDF)
First published:
Draft guideline on veterinary medicinal products controlling Varroa destructor parasitosis in bees - Revision 2
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CVMP/EWP/459883/2008 Rev.2
Summary:
This revision will replace the current version of the CVMP guideline on veterinary medicinal products controlling Varroa destructor parasitosis in bees (EMA/CVMP/EWP/459883/2008-Rev.1).
Comments should be provided using this template. The completed comments form should be sent to vet-guidelines@ema.europa.eu
English (EN) (320.48 KB - PDF)
First published:
Draft guideline for the evaluation of efficacy of ectoparasiticides - general requirements
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CVMP/EWP/507106/2023
Summary:
This guideline replaces the 'Guideline for demonstration of efficacy of ectoparasiticides' (7AE17a).
Comments should be provided using this template. The completed comments form should be sent to vet-guidelines@ema.europa.eu
English (EN) (339.68 KB - PDF)
First published:
Reflection paper on investigation and assessment of cardiovascular safety of anticancer medicinal products
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/8699/2026
Summary:
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (264.64 KB - PDF)
First published:
Concept paper for the development of a guideline on the assessment of the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product in non-food-producing animal species
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CVMP/AWP/109142/2025
Summary:
This concept paper proposes the development of a guideline to provide advice on data requirements and methodology for assessing the risk to public health from antimicrobial resistance due to the use of an antimicrobial veterinary medicinal product (VMP) in non-food-producing animal species to address regulatory requirements laid in Regulation (EU) 2019/6. In view of the experience and knowledge with antimicrobials for pets, the intended guideline will be developed with a focus on companion animals, although all non-food-producing animals are in scope.
Comments should be provided using this template. The complete comments form should be sent to awpsecretariat@ema.europa.eu
English (EN) (237.08 KB - PDF)
First published:
Draft guideline on non-inferiority and equivalence comparisons in clinical trials
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/301654/2025
Summary:
This guideline replaces the 'Guideline on the choice of the non-inferiority margin' (EMEA/CPMP/EWP/2158/99) and ‘Points to consider on switching between superiority and non-inferiority' (CPMP/EWP/482/99).
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (498.78 KB - PDF)
First published: