Open 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:

Templates

Template for submission of comments on scientific guidelines

English (EN) (232 KB - DOC)

First published: 27/01/2023

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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)

First published: 15/02/2023

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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

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First published: 14/02/2020

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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: 15/04/2025 to 15/07/2025Reference Number: EMA/HMPC/234781/2024

English (EN) (268.62 KB - PDF)

First published: 15/04/2025

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Quality Review of Documents (QRD) annotated template v11: Draft for public consultation

Draft: consultation openConsultation dates: 14/04/2025 to 31/08/2025Summary:

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)

First published: 14/04/2025

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ICH Guideline M13B on bioequivalence for immediate release solid oral dosage forms - additional strengths - Step 2b

Draft: consultation openConsultation dates: 09/04/2025 to 09/07/2025Reference 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: 09/04/2025

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Reflection paper on a tailored clinical approach in biosimilar development

Draft: consultation openConsultation dates: 01/04/2025 to 30/09/2025Reference 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:

EU survey: Submission of comments on the draft "Reflection paper on a tailored clinical approach in biosimilar development"

English (EN) (344.69 KB - PDF)