Open consultations
The list below includes the European Medicines Agency's (EMA) open public consultations.
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:
To submit comments specifically on ICH draft guidelines under consultation, use the form below:
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:
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Concept paper on the development of a Reflection Paper on modern manufacturing techniques used for herbal preparations (PDF/180.6 KB)
Reference numberEMA/HMPC/885124/2022StatusDraft: consultation openFirst published17/08/2023Consultation dates15/08/2023 to 15/11/2023
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Draft guideline on efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6 (PDF/289.99 KB)
Reference numberEMA/CVMP/EWP/231668/2022StatusDraft: consultation openFirst published21/07/2023Consultation dates21/07/2023 to 31/01/2024Email address for submissionsSummaryThis guideline clarifies the efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
Comments should be provided using this template.
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Concept paper on the revision of the guideline for the demonstration of efficacy of ectoparasiticides (PDF/204.49 KB)
Reference numberEMA/CVMP/EWP/56030/2023StatusDraft: consultation openFirst published21/07/2023Consultation dates21/07/2023 to 31/10/2023Email address for submissionsSummaryThis concept paper has been developed to address the proposed revision of the existing guideline for the demonstration of efficacy of ectoparasiticides (7AE17a) in order to provide clearer guidance and to align the guideline with current scientific and regulatory requirements.
Comments should be provided using this template.
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Draft guideline on quality data requirements for applications for veterinary medicinal products other than biologicals intended for limited markets (PDF/317.39 KB)
Reference numberEMA/CVMP/QWP/47285/2022StatusDraft: consultation openFirst published21/07/2023Consultation dates21/07/2023 to 31/01/2024Email address for submissions
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Concept paper on the revision of the guideline on 'Guideline on Radiopharmaceuticals based on monoclonal antibodies' (PDF/176.62 KB)
Reference numberEMA/CHMP/BWP/245588/2023StatusDraft: consultation openFirst published21/07/2023Consultation dates21/07/2023 to 31/10/2023SummaryThe proposed guideline will replace 'Guideline on Radiopharmaceuticals Based on Monoclonal Antibodies' (3AQ21a)
Comments should be provided using this EUSurvey form.
For any technical issues, please contact the EUSurvey Support.
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Concept paper on the revision of the 'Guideline on Radiopharmaceuticals - Revision 1' (PDF/201.49 KB)
Reference numberEMA/CHMP/QWP/298182/2023StatusDraft: consultation openFirst published21/07/2023Consultation dates21/07/2023 to 31/10/2023SummaryThe proposed guideline will replace 'Guideline on Radiopharmaceuticals - Revision 1' (EMEA/CHMP/QWP/306970/2007).
Comments should be provided using this EUSurvey form.
For any technical issues, please contact the EUSurvey Support.
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Concept paper for the development of a reflection paper on the availability and characteristics of diagnostic tests to improve the responsible use of antibiotics in animals (PDF/205.64 KB)
Reference numberEMA/CVMP/AWP/933451/2022StatusDraft: consultation openFirst published21/07/2023Consultation dates21/07/2023 to 31/10/2023Email address for submissionsSummaryThis concept paper proposes the development of a reflection paper on diagnostic tests to support the responsible use of antibiotics in animals and is aimed to address activities on this topic that are included in the CVMP’s Strategy on Antimicrobials, the European Medicines Agencies Network Strategy to 2025 and the EMA’s Regulatory Science Strategy.
Comments should be provided using this template.
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Draft reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle (PDF/297.17 KB)
Reference numberEMA/CHMP/CVMP/83833/2023StatusDraft: consultation openFirst published19/07/2023Consultation dates19/07/2023 to 31/12/2023SummaryEMA is seeking stakeholder feedback on the draft reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle via an open consultation concerning human and veterinary medicines. This consultation aims to initiate the dialogue with all groups of stakeholders in this fast evolving field. During the consultation a workshop will be organised by EMA on 20-21 November 2023 on AI in the context of medicines.
Please provide feedback by 31 December 2023 using the dedicated form.
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ICH reflection paper on proposed international harmonisation of real-world evidence terminology and convergence of general principles regarding planning and reporting of studies using real-world data, with a focus on effectiveness of medicines (PDF/390.54 KB)
Reference numberEMA/CHMP/ICH/295401/2023StatusDraft: consultation openFirst published06/07/2023Consultation dates30/06/2023 to 30/09/2023Email address for submissionsSummaryThe objectives of this reflection paper are to engage ICH on convergence of terminology for real-world data and real-world evidence, on the format for protocols and reports of study results submitted to regulatory agencies throughout the lifecycle of medicinal products, and on promoting registration of study protocols and reports.
This paper builds on the 2022 ICMRA statement on international collaboration to enable RWE for regulatory decision-making, and identifies areas for harmonisation in future ICH guidelines to ultimately inform the assessment of real-world data and real-world evidence for regulatory purposes.
For submission of comments, please use the standard ICH public consultation form
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Concept paper on the development of a guideline on the quality aspects of mRNA vaccines (PDF/175.99 KB)
Reference numberEMA/CHMP/BWP/211968/2023StatusDraft: consultation openFirst published23/06/2023Consultation dates23/06/2023 to 30/09/2023SummaryThis concept paper addresses the need to establish a guideline on the quality aspects of mRNA vaccines. The number of clinical trial applications for human products and marketing authorisation applications for mRNA containing products significantly increased over the last few years and is expected to increase further in the future. Furthermore, a lot of experience with mRNA vaccines was gained during the COVID-19 pandemic. From an analytical and regulatory perspective, mRNA vaccines are interesting since their classification depends on the target and/or whether they are obtained chemically or biologically.
mRNA vaccines against infectious disease have to align with the general guidance for human vaccines, however the new technology is not fully accounted for in the existing guidance. It is therefore proposed to establish a guideline addressing those specific aspects regarding the manufacturing process, characterisation, specifications and analytical control as well as the definition of active substance and finished product for mRNA vaccines for the prevention of infectious disease.
Comments should be provided using this EUSurvey form.
For any technical issues, please contact the EUSurvey Support.
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Concept paper for the revision of the guideline on live recombinant vector vaccines for veterinary use (PDF/158.52 KB)
Reference numberEMA/CVMP/IWP/161133/2023StatusDraft: consultation openFirst published23/06/2023Consultation dates23/06/2023 to 22/09/2023
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Pirfenidone film-coated tablets 267, 537 and 801 mg, and hard capsules 267 mg product-specific bioequivalence guidance (PDF/140.33 KB)
Reference numberEMA/CHMP/901584/2022StatusDraft: consultation openFirst published22/06/2023Consultation dates22/06/2023 to 30/09/2023Email address for submissions
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Metformin immediate-release film-coated tablets 500, 850 and 1000 mg product-specific bioequivalence guidance (PDF/141.33 KB)
Reference numberEMA/CHMP/591346/2022StatusDraft: consultation openFirst published22/06/2023Consultation dates22/06/2023 to 30/09/2023Email address for submissions
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Lurasidone film-coated tablets 18.5, 37 and 74 mg 4 product-specific bioequivalence guidance (PDF/156.88 KB)
Reference numberEMA/CHMP/39336/2023StatusDraft: consultation openFirst published22/06/2023Consultation dates22/06/2023 to 30/09/2023Email address for submissions
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Fampridine prolonged-release tablet 10 mg product specific bioequivalence guidance (PDF/147.05 KB)
Reference numberEMA/CHMP/39346/2023StatusDraft: consultation openFirst published22/06/2023Consultation dates22/06/2023 to 30/09/2023Email address for submissions
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Bosutinib film-coated tablets 100, 400 and 500 mg product-specific bioequivalence guidance (PDF/138.56 KB)
Reference numberEMA/CHMP/590937/2022StatusDraft: consultation openFirst published22/06/2023Consultation dates22/06/2023 to 30/09/2023Email address for submissions
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Call for scientific data for the use in HMPC assessment work on Maydis stigma (PDF/117.62 KB)
Reference numberEMA/HMPC/267698/2023StatusDraft: consultation openFirst published15/06/2023Consultation dates15/06/2023 to 15/09/2023
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Draft ICH E6 (R3) Guideline on good clinical practice (GCP) - Step 2b (PDF/774.37 KB)
Reference numberEMA/CHMP/ICH/135/1995StatusDraft: consultation openFirst published26/05/2023Consultation dates26/05/2023 to 26/09/2023Email address for submissionsSummaryThe objective of this ICH GCP Guideline is to provide a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory authorities.
This guideline builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies. This includes fostering a quality culture and proactively designing quality into clinical trials and drug development planning, identifying factors critical to trial quality, and engaging stakeholders, as appropriate, using a proportionate risk-based approach.For submission of comments please use specifically the following form ‘
Submission of comments on ICH E6 (R3) guideline '.
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Reflection paper on establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation (PDF/250.87 KB)
Reference numberEMA/CHMP/564424/2021StatusDraft: consultation openFirst published21/04/2023Consultation dates21/04/2023 to 30/09/2023Email address for submissions
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Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Glossary (PDF/162.95 KB)
Reference numberEMA/118227/2021StatusDraft: consultation openFirst published05/07/2021Email address for submissions
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