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:
Form for submission of comments on scientific guidelines
English (EN) (232 KB - DOC)
To submit comments specifically on ICH draft guidelines under consultation, use the form below:
Submission of comments on ICH guidelines
English (EN) (208.69 KB - XLSX)
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:
Call for scientific data for the periodic review of the monograph on Lini semen
English (EN) (148.4 KB - PDF)
Call for scientific data for the periodic review of the monograph on Lupuli flos
English (EN) (147.34 KB - PDF)
Call for scientific data for the periodic review of the monograph on Rusci rhizoma
English (EN) (148.6 KB - PDF)
Call for scientific data for the periodic review of the monograph on Sambuci flos
English (EN) (149.74 KB - PDF)
Call for scientific data for the periodic review of the monograph on Thymi herba and Primulae radix
English (EN) (152.39 KB - PDF)
ICH E2D(R1) Guideline on post-approval safety data Step 2b - Revision 1
English (EN) (908.45 KB - PDF)
VICH GL22(R) - Studies to evaluate the safety of residues of veterinary drugs in human food reproduction testing (Revision 1)
English (EN) (330.33 KB - PDF)
Draft guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations
English (EN) (408.45 KB - PDF)
Concept Paper for the Development of a Guideline on Non-Inferiority and Equivalence Comparisons in Clinical Trials
English (EN) (168.46 KB - PDF)
Draft guideline on live recombinant vector vaccines for veterinary use - Revision 1
This guideline provides guidance on the data to be submitted in the marketing authorisation application for the veterinary live recombinant vector vaccines.
Comments should be provided using this template. The completed comments form should be sent IWP@ema.europa.eu
English (EN) (236.82 KB - PDF)
Draft guideline on data requirements for veterinary medicinal products for zootechnical purposes - Revision 1
This guideline replaces the Guideline for veterinary medicinal products for zootechnical purposes (7AE7a)
Comments should be provided using this template. The completed comments form should be sent to vet-guidelines@ema.europa.eu.
English (EN) (271.31 KB - PDF)