Open consultations
The list below includes the European Medicines Agency's (EMA) open public consultations.
HumanVeterinaryScientific guidelines
On Monday, 12 January 2026, between 07:00 and 10:00 CET (Amsterdam time), this website will be unavailable due to scheduled maintenance.
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)
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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)
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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)
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Open consultations
Concept Paper on the revision of Annex 3 of the guidelines on Good Manufacturing Practice for Radiopharmaceuticals
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/INS/GMP/389655/2025
Summary:
This concept paper aims to outline the rationale, objectives, and proposed changes for updating the Annex 3, Manufacture of Radiopharmaceuticals, of the Good Manufacturing Practice (GMP) guide, that is common to the Member States of the European Union (EU)/European Economic Area (EEA) as well as to the Participating Authorities of the Pharmaceutical Inspection Co-operation Scheme (PIC/S). The aim of the revision is to provide guidance within some areas that were not covered in the current version issued in 2008, clarify some sections, and support innovative pharmaceutical manufacturing and control approaches.
Those participating in the public consultation are asked to please submit comments via the EU Survey tool.
English (EN) (197.45 KB - PDF)
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Last updated:
ICH E22 Guideline on general considerations for patient preference studies - Step 2b
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CHMP/ICH/371537/2025
Summary:
Comments should be provided using this template. The completed comments form should be sent to ich@ema.europa.eu
English (EN) (1.1 MB - PDF)
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Draft guideline on quality of radiopharmaceuticals - Revision 2
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CHMP/QWP/363827/2025
Summary:
This guideline replaces the ‘Guideline on Radiopharmaceuticals’ (EMEA/CHMP/QWP/306970/2007). Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (505.5 KB - PDF)
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Concept paper on the guideline revision on good pharmacogenomic practice
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/282050/2025
Summary:
The proposed revised guideline will replace the 'Guideline on good pharmacogenomic practice' (EMA/CHMP/718998/2016). Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (227.13 KB - PDF)
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Last updated:
Call for user acceptance testers for the read functionality in the Public Product Management Service (PMS) Application Programming Interface (API)
Draft: consultation open
Consultation dates:
to
English (EN) (159.43 KB - PDF)
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Concept paper on the need for revision of the guideline on clinical investigation of medicinal products in the treatment of Parkinson’s disease
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/322471/2025
Summary:
The proposed guideline will replace the Guideline on clinical investigation of medicinal products in the treatment of Parkison’s disease (EMA/CHMP/330418/2012 rev. 2, 7 July 2012).
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (207.78 KB - PDF)
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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)
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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)
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Draft qualification opinion for molecule-independent device bridging approach (MIDBA)
Draft: consultation open
Consultation dates:
to
Reference Number: EMADOC-1700519818-2552151
Summary:
Comments should be provided using this template. The completed comments form should be sent to ScientificAdvice@ema.europa.eu
English (EN) (221.84 KB - PDF)
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Draft guideline on quality aspects of phage therapy medicinal products
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CHMP/BWP/1/2024
Summary:
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (338.3 KB - PDF)
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Reflection paper on non-human primates in safety testing of human medicinal products and opportunities for 3Rs implementation
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CHMP/55697/2025
Summary:
This reflection paper aims to provide an overview of the scientific and regulatory considerations for non human primate use in safety testing of human medicinal products. It highlights the existing flexibility within published guidelines to incorporate 3Rs approaches and describes novel alternative approaches which may become available in the future. Notwithstanding the detailed conditions outlined herein, some important examples include; use of rodent species (including transgenics) only to evaluate repeat dose toxicity, the waiving of long-term (6 month) studies to evaluate the safety risk associated with monoclonal antibodies, the use of alternative assays to predict malformations or embryo-foetal lethality in developmental and reproductive toxicity.
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (375.44 KB - PDF)
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Concept paper on a paediatric update of the guideline on clinical investigation of medicinal products for the management of Crohn’s disease
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CHMP/312837/2025
Summary:
Deadline for comments has been extended to 31 January 2026. Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (181.22 KB - PDF)
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Last updated:
Concept paper on a paediatric update on the guideline on the development of new medicinal products for the treatment of Ulcerative Colitis
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CHMP/312843/2025
Summary:
Deadline for comments has been extended to 31 January 2026. Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (183.6 KB - PDF)
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Draft list of references supporting the assessment of Zea mays, L., stigma
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/HMPC/509422/2023
English (EN) (196.79 KB - PDF)
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Draft assessment report on Zea mays L., stigma
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/HMPC/509423/2023
English (EN) (558.8 KB - PDF)
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Draft European Union herbal monograph on Zea mays L., stigma
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/HMPC/509424/2023
English (EN) (238.82 KB - PDF)
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Draft guideline on the clinical evaluation of medicinal products intended for the treatment of chronic hepatitis B (CHB) - Revision 1
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/283093/2016 Rev. 1
Summary:
This guideline replaces the guideline on the clinical evaluation of medicinal products intended for the treatment of Hepatitis B (CHMP/EWP/6172/03). Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (416.36 KB - PDF)
First published:
Draft guideline on clinical investigation of medicinal products for the treatment of psoriatic arthritis - Revision 1
Draft: consultation open
Consultation dates:
to
Reference Number: CHMP/EWP/438/04 Rev. 1
Summary:
This guideline replaces the ‘guideline on clinical investigation of medicinal products for the treatment of psoriatic arthritis' (CHMP/EWP/438/04). Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (424.23 KB - PDF)
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Concept paper on new guidance on the clinical investigation of medicinal products for the treatment of idiopathic pulmonary fibrosis (IPF)
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CHMP/290364/2025
Summary:
Deadline for comments has been extended to 31 January 2026. Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (211.98 KB - PDF)
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Last updated:
Reflection paper on patient experience data
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CHMP/PRAC/148869/2025
Summary:
Comments should be provided using this form. The completed comments form should be sent to PED_RP@ema.europa.eu
English (EN) (544.8 KB - PDF)
First published: