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

To submit comments specifically on ICH draft guidelines under consultation, use the form below:

Submission of comments on ICH guidelines

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

European Medicines Agency’s privacy statement public and targeted consultations

Trametinib film-coated tablet 0.5 and 2mg product-specific bioequivalence guidance

Dabrafenib hard capsule 50 and 75 mg product-specific bioequivalence guidance

Call for scientific data for the periodic review of the monograph on Gentianae radix

Call for scientific data for the periodic review of the monograph on Calendulae flos

Call for scientific data for the periodic review of the monograph on Boldi folium

Call for scientific data for the periodic review of the monograph on Avenae herba

Call for scientific data for the periodic review of the monograph on Avenae fructus

Call for scientific data for the periodic review of the monograph on Lini semen

Call for scientific data for the periodic review of the monograph on Lupuli flos

Call for scientific data for the periodic review of the monograph on Rusci rhizoma

Call for scientific data for the periodic review of the monograph on Sambuci flos

Call for scientific data for the periodic review of the monograph on Thymi herba and Primulae radix

ICH E2D(R1) Guideline on post-approval safety data Step 2b - Revision 1

VICH GL22(R) - Studies to evaluate the safety of residues of veterinary drugs in human food reproduction testing (Revision 1)

Preliminary QIG Considerations regarding Pharmaceutical Process Models

Draft guideline on allergen products development for immunotherapy and allergy diagnosis in moderate to low-sized study populations

Concept paper on the development of a guideline on the non-clinical and clinical evaluation of antiviral medicinal products and monoclonal antibodies for the prevention and treatment of COVID-19

Concept Paper for the Development of a Guideline on Non-Inferiority and Equivalence Comparisons in Clinical Trials

Call for scientific data for the periodic review of the monograph on Cimicifugae rhizoma

Call for scientific data for the periodic review of the monograph on Ribis nigri folium


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