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)
To submit comments specifically on ICH draft guidelines under consultation, use the form below:
Submission of comments on ICH guidelines
English (EN) (208.69 KB - XLSX)
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:
Reflection paper on use of real-world data in non-interventional studies to generate real-world evidence
English (EN) (408.25 KB - PDF)
Guideline on stability testing for applications for variations to a marketing authorisation for veterinary medicinal products
English (EN) (298.63 KB - PDF)
Concept paper on revision of the Guideline on Risk Assessment of Medicinal Products on Human Reproduction and Lactation: from Data to Labelling
English (EN) (399.77 KB - PDF)
Ketoprofen : call for scientific data for use in CVMP assessment work of ketoprofen: review of the CVMP opinion for the establishment of maximum residue limits
English (EN) (147.59 KB - PDF)
Concept paper on the revision of the 'Guideline on epidemiological data on blood transmissible infections' - Revision 2
The guideline on epidemiological data on blood transmissible infections (EMA/CHMP/BWP/548524/2008 rev 1) outlines the scientific data requirements for epidemiological data on blood transmissible infections to be included in applications for Plasma Master File (PMF) certification or annual recertification submitted to the EMA.
The guideline requires that a system of alert limits for epidemiological data should be in place to identify individual blood/plasma collection centres with viral infections rates outside the normal range for the given donor population in the PMF (outliers) and to be able to take appropriate corrective actions, if needed. This is an essential part of the measures taken to ensure that donations do not come from donors with a high risk of being infected with blood transmissible agents.
In 2022, as part of a Q&A for PMF holders (PMF-Hs) (EMA/CHMP/BWP/721411/2022) additional guidance encouraged the usage of parametric models for establishing alert limits although clarified that non parametric models might be acceptable, if sufficiently justified.
In 2023, in view of the experience gathered during the review of the alert limits information in recent PMF annual updates (AU) and the requests from the plasma fractionation industry for further guidance, the need to expand the information for PMF holders on the approach and the statistical method for the appropriate calculation of alert limits was identified.
The revision and expansion on the alert limit calculations of the epidemiological guideline is proposed as part of the 3-year BWP workplan 2024-2026.
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (177.88 KB - PDF)
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
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.
English (EN) (140.62 KB - PDF)
Draft template for assessment report for the development of European herbal monographs and European Union list entries - Revision 6
English (EN) (499.78 KB - PDF)
Draft guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin - Revision 1
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.
English (EN) (398.17 KB - PDF)
Template for a European Union herbal monograph
English (EN) (304.95 KB - PDF)
Draft guideline on the pharmaceutical quality of inhalation and nasal medicinal products
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.
English (EN) (481.33 KB - PDF)
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
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.
English (EN) (625.03 KB - PDF)
Draft guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD)
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).
English (EN) (503.66 KB - PDF)
Draft guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials - Second version
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)
Trametinib film-coated tablet 0.5 and 2mg product-specific bioequivalence guidance
English (EN) (136.78 KB - PDF)
Dabrafenib hard capsule 50 and 75 mg product-specific bioequivalence guidance
English (EN) (136.5 KB - PDF)
Call for scientific data for the periodic review of the monograph on Gentianae radix
English (EN) (115.04 KB - PDF)
Call for scientific data for the periodic review of the monograph on Calendulae flos
English (EN) (117.78 KB - PDF)
Call for scientific data for the periodic review of the monograph on Boldi folium
English (EN) (114.48 KB - PDF)
Call for scientific data for the periodic review of the monograph on Avenae herba
English (EN) (114.61 KB - PDF)
Call for scientific data for the periodic review of the monograph on Avenae fructus
English (EN) (114.75 KB - PDF)