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)
First published:
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
Draft concept paper on the development of a reflection paper on the use of external controls for evidence generation in regulatory decision-making
Draft: consultation openConsultation dates:
to Reference Number: EMA/CHMP/225255/2025Summary:
Randomised controlled trials are the gold standard of evidence to support causal conclusions on the benefits and risks of medicines in regulatory decision making along the lifecycle.
However, in some situations, causal conclusions may be derived from a setting where the investigational medicinal product data was collected under a clinical trial protocol while the control arm was not a randomized arm in that same protocol. In these situations, a so-called external control, may be derived from data from other clinical trials, real-world data (RWD) or other data sources.
A reflection paper shall be drafted to describe the main challenges with external controls and further discuss the circumstances and methodological constraints under which the use of external controls could be considered appropriate for generating pivotal or supportive evidence, either for efficacy, safety or other relevant regulatory decision-making objectives.
This concept paper outlines the scope and content of the reflection paper.
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support .
English (EN) (157.56 KB - PDF)
First published:
Dronedarone film-coated tablets 400 mg product-specific bioequivalence guidance - Revision 1
Draft: consultation openConsultation dates:
to Reference Number: EMA/151695/2025 Rev. 1
English (EN) (158.79 KB - PDF)
First published:
Aliskiren film-coated tablet 150 mg and 300 mg product-specific bioequivalence guidance - Revision 1
Draft: consultation openConsultation dates:
to Reference Number: EMA/151687/2025 Rev. 1
English (EN) (185.42 KB - PDF)
First published:
Sirolimus coated tablets 0.5, 1 and 2 mg, oral solution 1 mg/ml product-specific bioequivalence guidance - Revision 1
Draft: consultation openConsultation dates:
to Reference Number: EMA/151700/2025 Rev. 1*
English (EN) (173.8 KB - PDF)
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ICH E20 guideline on adaptive designs for clinical trials - Step 2b
Draft: consultation openConsultation dates:
to Reference Number: EMA/CHMP/ICH/206586/2025Summary:
This document provides guidance on confirmatory clinical trials planned with an adaptive design within the context of its overall development programme, allowing pre-specified modifications of the trial design based on an interim analysis of the on-going trial.
Comments should be provided using this template. The completed comments form should be sent to ich@ema.europa.eu
English (EN) (904.75 KB - PDF)
First published:
Reflection paper on lessons learned from the COVID-19 pandemic: Scientific considerations on non-clinical aspects
Draft: consultation openConsultation dates:
to Reference Number: EMA/CHMP/55697/2025
English (EN) (287.69 KB - PDF)
First published:
ICH M4Q(R2) : Guideline on the Common Technical Document for the registration of pharmaceuticals for human use - Quality - Step 2b
Draft: consultation openConsultation dates:
to Reference Number: EMA/CHMP/ICH/178042/2025
English (EN) (1.03 MB - PDF)
First published:
Concept paper on the need for revision of note for guidance on quality aspects of pharmaceutical veterinary medicines for administration via drinking water
Draft: consultation openConsultation dates:
to Reference Number: EMA/CVMP/QWP/85848/2025Summary:
This concept paper addresses the need to complement the guideline on Quality Aspects of Pharmaceutical Veterinary Medicines for administration via drinking water (EMEA/CVMP/540/03 Rev.1) with information relating to the administration of veterinary medicinal products in liquid feeds.
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (153.28 KB - PDF)
First published:
Concept paper for the development of a guideline on the methodology of environmental risk assessment for ectoparasiticidal VMPs for cats and dogs
Draft: consultation openConsultation dates:
to Reference Number: EMA/CVMP/ERA/499198/2024Summary:
This concept paper aims to outline the CVMP's approach regarding the elaboration of guidance on the assessment methodology to be used where the current default assumptions are not considered to be appropriate for ectoparasiticidal VMPs, including the nature of data to be provided in such cases.
Comments should be provided using this template. The completed comments form should be sent to vet-guidelines@ema.europa.eu
English (EN) (266.55 KB - PDF)
First published:
Draft chapter 9 of guideline on epidemiological data on blood transmissible infections
Draft: consultation openConsultation dates:
to Reference Number: EMA/CHMP/BWP/548524/2008 rev 2Summary:
This revision is only revising chapter 9 of the full guideline: Guideline for epidemiological data on blood transmissible infections. Upon finalisation the chapter 9 will be merged in the full guideline.
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (345.61 KB - PDF)
First published:
Concept paper on the new reflection paper on the clinical investigation of medicinal products for the treatment of systemic sclerosis
Draft: consultation openConsultation dates:
to Reference Number: EMA/179449/2025
English (EN) (217.89 KB - PDF)
First published:
ICH E21 Guideline on inclusion of pregnant and breastfeeding individuals in clinical trials
Draft: consultation openConsultation dates:
to Reference Number: EMA/CHMP/ICH/149462/2025Summary:
Comments should be provided using this template. The completed comments form should be sent to ich@ema.europa.eu.
English (EN) (1001.8 KB - PDF)
First published:
Draft European Union herbal monograph on Ononis spinosa L., radix - Revision 1
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/584455/2023 Rev 1Summary:
Comments should be provided using this template to hmpc.secretariat@ema.europa.eu
English (EN) (264.28 KB - PDF)
First published:
Draft reflection paper on data recommendations for herbal medicinal products and traditional herbal medicinal products used in children and adolescents
Draft: consultation openConsultation dates:
to Reference Number: EMA/HMPC/71333/2023Summary:
Comments should be provided using this template to hmpc.secretariat@ema.europa.eu
English (EN) (292.63 KB - PDF)
First published:
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) (190.9 KB - PDF)
First published:
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)
First published:
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)
First published:
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)
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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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: