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:

Form 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:

Submission of comments on ICH guidelines

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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

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First published: 27/01/2023

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European Medicines Agency’s privacy statement public and targeted consultations

Reference Number: EMA/472380/2019

English (EN) (134.32 KB - PDF)

First published: 14/02/2020

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Concept paper for the development of a guideline on the safety of nanoparticles – in the context of the establishment of maximum residue limits and veterinary marketing authorisations

Consultation dates: 26/04/2024 to 31/07/2024Draft: consultation openReference Number: EMA/CVMP/NTWP/143787/2023Summary:

This concept paper addresses the need for a specific guideline on the establishment of maximum residue limits (MRLs) for pharmacologically active nanoparticles, as well as on safety for veterinary medicinal products (VMPs) containing nanoparticles.

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First published: 26/04/2024

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Draft template for assessment report for the development of European herbal monographs and European Union list entries - Revision 6

Consultation dates: 15/04/2024 to 15/07/2024Draft: consultation openReference Number: EMA/HMPC/418902/2005 Rev. 6

English (EN) (499.78 KB - PDF)

First published: 18/04/2024

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Draft guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin - Revision 1

Consultation dates: 15/04/2024 to 15/07/2024Draft: consultation openReference Number: EMEA/HMPC/246816/2005 Rev. 1Summary:

This guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin came into effect in August 2006 and is intended to provide guidance to ensure appropriate and consistent quality of herbal substances1. The current Revision 1 of the GACP guideline pertains to an update of the document to current standards taking into account advances over the last 10 years, as for instance, the increased development of indoor growing technologies, and also cover the established practice and legal interpretations published during this period.

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First published: 18/04/2024

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Template for a European Union herbal monograph

Consultation dates: 15/04/2024 to 15/07/2024Draft: consultation openReference Number: EMA/HMPC/107436/2005 Rev. 8

English (EN) (304.95 KB - PDF)

First published: 15/04/2024

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Draft guideline on the pharmaceutical quality of inhalation and nasal medicinal products

Consultation dates: 12/04/2024 to 31/10/2024Draft: consultation openReference Number: EMA/CHMP/20607/2024Summary:

This guideline replaces the guideline on pharmaceutical quality of inhalation and nasal products (EMEA/CHMP/QWP/49313/2005 Corr) and Quality of medicines questions and answers: Part 2 Specific type of products – Dry product inhalers; Orally inhaled products; Storage – What are the requirements for storage orientation recommendations in the product information for pressurised metered dose inhalers.

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First published: 12/04/2024

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Draft revised Heads of Medicines Agency / European Medicines Agency guidance document on the identification of personal data and commercially confidential information within the structure of the marketing authorisation application dossier

Consultation dates: 12/04/2024 to 28/06/2024Draft: consultation openSummary:

This guidance document is intended to be applicable to information/documents pertaining to the initial and variation of marketing authorisation application (MAA) dossiers of medicinal products for human use for which the regulatory procedure has been finalised, under the national, mutual recognition, decentralised and centralised procedures. “Finalised” shall mean that the marketing authorisation (MA) has been granted or refused or that the MAA has been withdrawn.

By extension, the principles laid down in this guidance can be considered for other types of finalised procedures such as orphan designations, Paediatric Investigation Plans (PIPs)/waivers or scientific advice. The application of the general principles laid down in this guidance is without prejudice to national rules on transparency. The guidance should be read in conjunction with the relevant applicable legislation and case law on transparency and data protection.

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First published: 12/04/2024

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Draft guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD)

Consultation dates: 12/04/2024 to 30/10/2024Draft: consultation openReference Number: EMA/CHMP/101453/2024Summary:

This guideline replaces "Guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for use in the treatment of asthma in children and adolescents (CPMP/EWP/4151/00 Rev. 1).

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First published: 12/04/2024

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Draft guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials - Second version

Consultation dates: 25/03/2024 to 31/05/2024Draft: consultation openReference Number: EMA/CAT/123573/2024Summary:

This guideline provides guidance on the structure and data requirements for a clinical trial application for exploratory and confirmatory trials with advanced therapy investigational medicinal products.

Note: This is a short, second public consultation for the guideline. All comments received during the first public consultation have been reviewed and incorporated, where possible, in this guideline. Stakeholders can consult the ‘Overview of comments’ document: comments submitted on the first version of this guideline should not be resubmitted.

English (EN) (827.17 KB - PDF)

First published: 25/03/2024

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Trametinib film-coated tablet 0.5 and 2mg product-specific bioequivalence guidance

Consultation dates: 11/03/2024 to 30/06/2024Draft: consultation openReference Number: EMA/CHMP/41624/2023

English (EN) (136.78 KB - PDF)

First published: 11/03/2024

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Dabrafenib hard capsule 50 and 75 mg product-specific bioequivalence guidance

Consultation dates: 11/03/2024 to 30/06/2024Draft: consultation openReference Number: EMA/CHMP/39771/2023

English (EN) (136.5 KB - PDF)

First published: 11/03/2024

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Call for scientific data for the periodic review of the monograph on Gentianae radix

Consultation dates: 01/03/2024 to 31/05/2024Draft: consultation openReference Number: EMA/91109/2024

English (EN) (115.04 KB - PDF)