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 revision of the guideline on the principles of regulatory acceptance of 3Rs (replacement, reduction, refinement) testing approaches (PDF/208.8 KB)
Reference numberEMA/CHMP/CVMP/452614/2023StatusDraft: consultation openFirst published23/11/2023Consultation dates20/11/2023 to 28/02/2024SummaryThis guideline aims to encourage stakeholders and authorities to initiate, support and accept development and use of 3Rs testing approaches with the aim to replace, reduce and refine in vivo animal studies for human and veterinary medicinal products.
Comments should be provided using this EUSurvey form.
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Addendum to EMA/CHMP/CVMP/QWP/17760/2009 Rev 3: Defining the Scope of an NIRS Procedure (PDF/252.56 KB)
Reference numberEMA/CHMP/CVMP/QWP/17760/2009StatusDraft: consultation openFirst published13/11/2023Consultation dates10/11/2023 to 22/12/2023SummaryThe "Guideline on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations” introduced the concept of the NIRS procedure scope. An addendum was published in 2014 to exemplify the scope and how changes should be reported to EU regulatory authorities. Based on experience of regulators to date, it is proposed to amend this addendum, to facilitate continuous improvement and lifecycle management of NIRS procedures.
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Implementation strategy of ICH Guideline M10 on bioanalytical method validation (PDF/146.03 KB)
Reference numberEMA/449486/20233StatusDraft: consultation openFirst published13/11/2023Consultation dates10/11/2023 to 31/01/2024SummaryThe purpose of this document is to address specific considerations to enable the practical implementation of ICH Guideline M10 on bioanalytical method validation in the European Union.
Comments should be provided using this template. The completed comments form should be sent to mwp@ema.europa.eu
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Draft guideline on clinical investigation of medicinal products in the treatment of epileptic disorders - Revision 3 (PDF/997.26 KB)
Reference numberCHMP/EWP/566/98 Rev. 3StatusDraft: consultation openFirst published13/11/2023Last updated13/11/2023Consultation dates10/11/2023 to 30/01/2024
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Concept paper on the development of an addendum to the Guideline on clinical development of vaccines on clinical trials for vaccines for immunocompromised individuals (PDF/185.17 KB)
Reference numberEMA/CHMP/453562/2023StatusDraft: consultation openFirst published03/11/2023Consultation dates01/11/2023 to 01/01/2024SummaryComments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
Keywords: immunocompromised, clinical trials, immunogenicity, vaccines
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Draft guideline on the clinical requirements for non replacement therapy in haemophilia A and B (PDF/275.13 KB)
Reference numberEMA/CHMP/453562/2023StatusDraft: consultation openFirst published31/10/2023Consultation dates01/11/2023 to 30/01/2024
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Concept paper on the revision of the Non-clinical and Clinical Module of the influenza vaccines guideline (PDF/177.49 KB)
StatusDraft: consultation openFirst published31/10/2023Consultation dates01/11/2023 to 30/01/2024SummaryThe proposed guideline will replace Guideline on influenza vaccines, non-clinical and clinical modules (EMA/CHMP/VWP/457259/2014).
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
Keywords: Vaccine platforms, mRNA, immunobridging, effectiveness, influenza, pandemic influenza, zoonotic vaccine, regulatory requirements
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Draft revised consolidated 3-year work plan for the Methodology Working Party (MWP) (PDF/246.96 KB)
Reference numberEMA/CHMP/478317/2023StatusDraft: consultation openFirst published31/10/2023Consultation dates01/11/2023 to 30/11/2023SummaryThe Methodology Working Party workplan constitutes the roadmap of MWP activities on the basis of evolving identified priorities. The updated workplan has been adopted by EMA’s human medicines committee (CHMP) and is now open for public consultation.
All key stakeholders are therefore encouraged to provide their feedback through the EU survey by 30 November 2023.
If you respond on behalf of a company that is affiliated with an EU (trade) industry organisations, you are encouraged to share your comments to the respective affiliated EU (Trade) Industry organisation.
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Draft guideline on the development and manufacture of Synthetic Peptides (PDF/401.76 KB)
Reference numberEMA/CHMP/CVMP/QWP/387541/2023StatusDraft: consultation openFirst published18/10/2023Consultation dates18/10/2023 to 30/04/2024
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Draft European Union herbal monograph on Pelargonium sidoides DC; Pelargonium reniforme Curt., radix - Revision 2 (PDF/167.12 KB)
Reference numberEMA/HMPC/648100/2022StatusDraft: consultation openFirst published16/10/2023Consultation dates15/10/2023 to 15/01/2024
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Concept paper on a guideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal products (PDF/172.54 KB)
Reference numberEMA/CVMP/QWP/348098/2023StatusDraft: consultation openFirst published13/10/2023Consultation dates13/10/2023 to 05/01/2024
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Concept paper on the revision of the Guideline on user safety of topically administered veterinary medicinal products (EMA/CVMP/SWP/721059/2014) (PDF/170.11 KB)
Reference numberEMA/CVMP/SWP/104211/2023StatusDraft: consultation openFirst published15/09/2023Consultation dates15/09/2023 to 30/11/2023SummaryThe proposed guideline will revise and replace 'Guideline on user safety of topically administered veterinary medicinal products’ (EMA/CVMP/SWP/721059/2014)
Keywords: user safety, topically administered veterinary medicinal products
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Guideline on safety and residue 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/301.63 KB)
Reference numberEMA/CVMP/SWP/32027/2022StatusDraft: consultation openFirst published15/09/2023Consultation dates15/09/2023 to 31/01/2024Email address for submissionsSummaryThis guideline clarifies the safety and residue 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.
Keywords: Availability, limited market, Article 4, Article 8, Article 23, eligibility, Regulation (EU) 2019/6, safety data, residue data
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Guideline on safety and efficacy data requirements for applications for immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6 (PDF/242.66 KB)
Reference numberEMA/CVMP/IWP/224724/2022StatusDraft: consultation openFirst published15/09/2023Consultation dates15/09/2023 to 31/01/2024
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Guideline on quality data requirements for applications for biological veterinary medicinal products intended for limited markets (PDF/218.39 KB)
Reference numberEMA/CVMP/IWP/228730/2022StatusDraft: consultation openFirst published15/09/2023Consultation dates07/09/2023 to 31/01/2024SummaryThe aim of this guidance is to define acceptable data requirements for the demonstration of the quality of biological veterinary medicinal products, including immunological veterinary medicinal (IVMPs) products, classified as limited markets in line with Article 4(29) of Regulation (EU) 2019/6.
Keywords: Availability, limited market, Article 4, Article 8, Article 23, Regulation (EU) 2019/6, quality data requirements for biological veterinary medicinal products
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Draft guideline on clinical investigation of medicinal products in the treatment of depression - Revision 3 (PDF/541.2 KB)
Reference numberEMA/CHMP/185423/2010 Rev.3StatusDraft: consultation openFirst published07/09/2023Last updated15/09/2023Consultation dates15/09/2023 to 31/03/2024SummaryThe present document should be considered as general guidance on the development of medicinal products for acute and long-term treatment of Major Depressive Disorder (MDD). It updates and replaces the previous guideline (EMA/CHMP/185423/2010 Rev. 2). The main focus is on major depressive episodes that occur in the context of MDD. Bipolar and related disorders are separated from the depressive disorders in DSM-5 and possible extrapolations in alignment with the bipolar guidance document will also be addressed.
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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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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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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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Draft list of references supporting the assessment of Panax ginseng C.A. Mey., radix - Revision 1 (PDF/341.65 KB)
Reference numberEMA/HMPC/27746/2023StatusDraft: consultation openFirst published15/06/2023Last updated25/10/2023Consultation dates19/10/2023 to 15/01/2024
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Draft European Union herbal monograph on Panax ginseng C.A.Mey., radix - Revision 1 (PDF/221.58 KB)
Reference numberEMA/HMPC/27744/2023StatusDraft: consultation openFirst published15/06/2023Last updated25/10/2023Consultation dates19/10/2023 to 15/01/2024
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