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)
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)
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
English (EN) (134.32 KB - PDF)
Open consultations
Concept paper on clinical evaluation of therapeutic radiopharmaceuticals in oncology
English (EN) (174.76 KB - PDF)
EMA policy on handling of competing interests of scientific committee members and experts: Draft for public consultation
EMA has opened a public consultation on the draft revised policy on handling of competing interests of scientific committee members and experts (‘Policy 0044’), following endorsement by the EMA Management Board.
Stakeholders are invited to comment using this EUSurvey form no later than 10 November 2024.
For any technical issues, please contact the EUSurvey Support.
English (EN) (373.57 KB - PDF)
Seizing opportunities in a changing medicines landscape: The European medicines agencies network strategy 2028 (draft)
The European Medicines Agencies Network Strategy to 2028 will guide the network as it seizes opportunities and meets the challenges of the near future. This includes preparing for and responding to public health emergencies and threats such as antimicrobial resistance.
Comments should be provided using the EU survey form below:
Public consultation on European Medicines Agencies Network Strategy to 2028
English (EN) (221.32 KB - PDF)
Draft guideline on risk management requirements for elemental impurities in veterinary medicinal products - Revision 3
This guideline replaces the Reflection paper on risk management requirements for elemental impurities in veterinary medicinal products, EMA/CVMP/QWP/153641/2018 and the Implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products, EMA/CVMP/QWP/631010/2017-Rev.2.
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (356.41 KB - PDF)
Questions and answers regarding co-processed excipients used in solid oral dosage forms (H & V)
This Q&A outlines the quality requirements for co-processed excipients (CoPE) used in solid oral dosage forms in both human and veterinary medicinal products. The use of CoPEs in pharmaceutical formulations is considered to have a higher degree of risk than using individual excipients due to several factors: for example complexity of composition, quality control, formulation development and stability issues. The Q&A aims to harmonise and quality clarify dossier requirements for CoPEs using a risk-based approach. It defines three risk categories for the CoPE and the risk factors the MAH/applicant should consider to identify the adequate risk category, and the related quality dossier requirements, which need to be provided by the MAH/applicants as part of new MAA or variations.
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support .
English (EN) (351.46 KB - PDF)
Draft guideline on clinical development of medicinal products for the treatment and prevention of bipolar disorder - Revision 1
This guideline replaces Guideline on clinical investigation of medicinal products in the treatment and prevention of bipolar disorder (CPMP/EWP/567/98).
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (379.99 KB - PDF)
European Union herbal monograph on plantaginis lanceolatae folium – Revision 1
English (EN) (278.83 KB - PDF)
Draft European Union herbal monograph on Cisti cretici herba – First version
English (EN) (187.98 KB - PDF)
Concept paper on the need for a reflection paper on assessment of cardiovascular safety of oncology medicinal products
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (201.37 KB - PDF)
Concept paper on the revision of the guideline on dossier requirements for anticancer medicinal products for dogs and cats
Comments should be provided using this template. The completed comments form should be sent to vet-guidelines@ema.europa.eu
English (EN) (173.33 KB - PDF)
Concept paper on the revision of the guideline on veterinary medicinal products controlling Varroa destructor parasitosis in bees
Comments should be provided using this template. The completed comments form should be sent to vet-guidelines@ema.europa.eu
English (EN) (186.84 KB - PDF)
Concept paper for the revision of the guideline on the conduct of bioequivalence studies for veterinary medicinal products (EMA/CVMP/016/2000-Rev.4)
Comments should be provided using this template. The completed comments form should be sent to vet-guidelines@ema.europa.eu
English (EN) (195.4 KB - PDF)
Concept paper on the revision of the guideline on user safety for pharmaceutical veterinary medicinal products (EMA/CVMP/543/03-Rev.1)
Comments should be provided using this template. The completed comments form should be sent to vet-guidelines@ema.europa.eu
English (EN) (198.42 KB - PDF)
Tolvaptan tablets with the dose range 7.5, 15 and 30 mg and tolvaptan tablets with the dose range 15, 30, 45, 60 and 90 mg product-specific bioequivalence guidance
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support .
English (EN) (117.27 KB - PDF)
Concept paper for the development of a guideline on the demonstration of therapeutic equivalence for nasal products
The aim of this new guideline is to detail the data requirements for demonstrating therapeutic equivalence between nasal products containing the same active moiety (ies), as these are currently insufficiently covered in existing guidelines.
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey support.
English (EN) (209.4 KB - PDF)
Draft guideline on the chemistry of active substances - Revision 1
Guideline concerning the application of Directive 2001/83/EC with a view to the granting of a marketing authorisation for a medicinal product. This guideline replaces the ‘Note for guidance on chemistry of new active substances’ (CPMP/QWP/130/96, Rev 1) and ‘Chemistry of active substances’ (3AQ5a). It has been revised to cover new and existing active substances in one guideline.
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (363.64 KB - PDF)
Draft guideline on the development and manufacture of oligonucleotides
This guideline addresses specific aspects regarding the manufacturing process, characterisation, specifications and analytical control for synthetic oligonucleotides which are not covered in the Guideline on the Chemistry of Active Substances (EMA/454576/2016) or Chemistry of Active Substances for Veterinary Medicinal Products (EMA/CVMP/QWP/707366/2017). It also contains requirements and considerations related to conjugation, to active substance in solution, to medicinal60
product development, to oligonucleotide generics development, to oligonucleotide personalised medicine approaches and to clinical trial applications (human products only).
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (432.97 KB - PDF)
Addendum to the Guideline on clinical development of vaccines to address clinical trials in immunocompromised individuals
This Addendum to the guideline provides guidance on clinical studies to be conducted in immunocompromised individuals before or after initial marketing authorization of vaccines in order to support recommendations for use in the Product Information.
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (200.94 KB - PDF)
Draft VICH GL23 Studies to evaluate the safety of residues of veterinary drugs in human food: genotoxicity testing - Revision 2
This Guideline has been developed by the appropriate VICH Expert Working Group and is subject to consultation by the parties, in accordance with the VICH Process. At Step 7 of the Process the final draft will be recommended for adoption to the regulatory bodies of the European Union, Japan and
USA.
Comments should be provided using this template. The completed comments form should be sent to vet-guidelines@ema.europa.eu.
English (EN) (396.18 KB - PDF)
Draft guideline on the conduct of efficacy studies for intramammary products for use in cattle
This guideline provides guidance on design, conduct and reporting of pre-clinical studies and clinical trials or veterinary medicinal products for intramammary use in dairy cattle. The current revision consists of changes made to align the guideline with the relevant provisions of Regulation (EU) 2019/6.
Comments should be provided using this template. The completed comments form should be sent to vet-guidelines@ema.europa.eu.
English (EN) (368.46 KB - PDF)