Open consultations
The list below includes the European Medicines Agency's (EMA) open public consultations.
HumanVeterinaryScientific guidelines
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)
First published:
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)
First published:
Open consultations
Concept paper on the development of a guideline on consumer safety of active substances of immunological veterinary medicinal products acting against endogenous targets
Draft: consultation openConsultation dates:
to Reference Number: EMA/CVMP/SWP/564861/2023Summary:
Comments should be provided using this template. The completed comments form should be sent to vet-guidelines@ema.europa.eu
English (EN) (173.21 KB - PDF)
First published:
Draft qualification opinion for Simcyp Simulator
Draft: consultation openConsultation dates:
to Reference Number: EMADOC-1700519818-2006369Summary:
Comments should be provided using this template. The completed comments form should be sent to ScientificAdvice@ema.europa.eu
English (EN) (1.22 MB - PDF)
First published:
Concept paper on the revision of Part IV guidelines on good manufacturing practice specific to advanced therapy medicinal products
Draft: consultation openConsultation dates:
to Reference Number: EMA/INS/GMP/48771/2025Summary:
This concept paper aims to outline the rationale, objectives, and proposed changes for updating Part IV – GMP specific to ATMP of the good manufacturing practice (GMP) guide Eudralex Volume 4 following the revision of Annex 1 which came into operation in August 2023. As the Part IV is an EU standalone guideline and that the sector is to abide solely for reference, it should be revised independently to address recent developments in the manufacture of sterile medicinal products.
Those participating in the public consultation are asked to please submit comments via the EU Survey tool.
English (EN) (113.06 KB - PDF)
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Concept paper on the revision of the guideline on the evaluation of anticancer medicinal products and appendices - Revision 7
Draft: consultation openConsultation dates:
to Reference Number: EMA/122980/2025
English (EN) (208.59 KB - PDF)
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Draft ICH Q1 guideline on stability testing of drug substances and drug products - Step 2b
Draft: consultation openConsultation dates:
to Reference Number: EMA/CHMP/ICH/130561/2025Summary:
Comments should be provided using this template. The completed comments form should be sent to ich@ema.europa.eu
English (EN) (2.1 MB - PDF)
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Concept paper for the development of a reflection paper on the assessment of public health risks related to antimicrobial resistance acquired via the environment, resulting from the use of a veterinary medicinal product
Draft: consultation openConsultation dates:
to Reference Number: EMA/CVMP/ERA/75412/2023Summary:
This concept paper provides background to the intended development of a scientific approach for use in the evaluation of the risk for humans exposed to antimicrobial resistance via the environment, originating from use of veterinary medicinal products. It is intended to provide advice on how relevant dossier requirements outlined in Regulation (EU) 2019/6 (e.g., Article 8(2)) may be fulfilled.
Comments should be provided using this template. The completed comments form should be sent to vet-guidelines@ema.europa.eu
English (EN) (234.71 KB - PDF)
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Call for scientific data for the use in HMPC assessment work on Valerianae radix and Passiflorae herba
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/125437/2025
English (EN) (119.82 KB - PDF)
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Draft assessment report on Allium sativum L., bulbus
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/329433/2024
English (EN) (739.04 KB - PDF)
First published:
Draft list of references supporting the assessment of Allium sativum L., bulbus
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/329434/2024
English (EN) (257.72 KB - PDF)
First published:
Draft European Union herbal monograph on Allium sativum L., bulbus
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/329435/2024
English (EN) (256.78 KB - PDF)
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Draft assessment report on Arnica montana L., flos
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/432016/2024
English (EN) (578.15 KB - PDF)
First published:
Draft list of references supporting the assessment of Arnica montana L., flos
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/524584/2024
English (EN) (199.12 KB - PDF)
First published:
Draft European Union herbal monograph on Arnica montana L., flos
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/524586/2024
English (EN) (255.96 KB - PDF)
First published:
Draft assessment report on Crataegus monogyna Jacq. (Lindm.), C. laevigata (Poir.) DC. or their hybrids; C. pentagyna Waldst. et Kit. ex Willd.; C. azarolus L.
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/116318/2024
English (EN) (815.06 KB - PDF)
First published:
Draft list of references supporting the assessment of Crataegus monogyna Jacq. (Lindm.), C. laevigata (Poir.) DC. or their hybrids; C. pentagyna Waldst. et Kit. ex Willd.; C. azarolus L.
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/234780/2024
English (EN) (189.81 KB - PDF)
First published:
Draft European Union herbal monograph on Crataegus monogyna Jacq. (Lindm.), C. laevigata (Poir.) DC. or their hybrids; C. pentagyna Waldst. et Kit. ex Willd.; C. azarolus L.
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/234781/2024
English (EN) (268.62 KB - PDF)
First published:
Quality Review of Documents (QRD) annotated template v11: Draft for public consultation
Draft: consultation openConsultation dates:
to Summary:
The ongoing revision of the QRD template started in September 2023, mainly triggered by the Report from the Commission to the European Parliament and the Council in accordance with Article 59(4) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. This report is an assessment of shortcomings in the summary of product characteristics (SmPC) and the package leaflet (PL), and it provides some recommendations on how they could be improved to better meet the needs of patients and healthcare professionals.
In addition, the revision has also considered the extensive experience gained over the years by the EMA Labelling Office and the QRD members, the voice of patients, consumers and healthcare professionals, the feedback provided by stakeholders performing consultation with target patients’ groups (so called user testing), and the work performed by some industry stakeholders on the improvement of the PL.
English (EN) (725.74 KB - PDF)
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Key information section in package leaflet of centrally authorised medicinal products: Public consultation
Draft: consultation openConsultation dates:
to Summary:
The European Medicines Agency (EMA) and the Quality Review of Documents (QRD) Working Group are currently working on the revision of the QRD template for centrally authorised medicinal products for human use, with the aim of improving the content and structure of the package leaflet and making it more understandable and relevant to patients, while still complying with the current legislative framework. The draft revised QRD template has been released for public consultation until 31 August 2025.
Separate from the public consultation of the QRD template, EMA would like to gather the views of stakeholders on the potential usefulness and added value of a new “key information section” in the package leaflet. The addition of this new section addresses one of the recommendations in the Report from the Commission to the European Parliament and the Council in accordance with Article 59(4) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, and it would allow patients, users and healthcare professionals to rapidly identify key safety messages, balanced with information on the benefit-risk profile of the medicine.
As concluded in the report, the evidence and views collected may help inform the decision on whether such a key information section in the package leaflet is needed and, if so, what type of information should be provided therein.
EMA would like to invite all interested stakeholders to respond to the following survey by 31 May 2025: EU Survey: Potential inclusion of key information section in package leaflet of centrally authorised medicines - public consultation.
More information is available: Product-information (QRD) templates - Human.
English (EN) (117.25 KB - PDF)
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ICH Guideline M13B on bioequivalence for immediate release solid oral dosage forms - additional strengths - Step 2b
Draft: consultation openConsultation dates:
to Reference Number: EMA/CHMP/ICH/85092/2025Summary:
This guideline is intended to provide recommendations on obtaining waivers of bioequivalence (BE) studies for one or more additional strengths of a drug product in an application where in vivo BE has been demonstrated for at least one of the strengths. The guideline is applicable during both development and post-approval phases of orally administered immediate release (IR) solid dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension.
Comments should be provided using this template. The completed comments form should be sent to ich@ema.europa.eu
English (EN) (1.66 MB - PDF)
First published:
Reflection paper on a tailored clinical approach in biosimilar development
Draft: consultation openConsultation dates:
to Reference Number: EMA/CHMP/BMWP/60916/2025Summary:
This is a draft reflection paper on a tailored clinical approach in biosimilardevelopment and evaluation is available for public consultation.
This approach could reduce the amount of clinical data required to develop and approvebiosimilar medicines.
Stakeholders can comment on the reflection paper until 30 September 2025 via the EU survey below:
English (EN) (344.69 KB - PDF)
First published: