Open consultations - Scientific guideline
Browse the European Medicines Agency's open public consultations and find information on how to submit your comments.
Scientific guidelineHumanVeterinaryHerbalScientific guidelines
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Use the dedicated EUSurvey link or consultation template in the relevant consultation document to submit your comments.
EMA publishes all comments received during the consultation on the dedicated guidance page.
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Templates
You can also find the standard consultation templates in the relevant consultation document.
Template for submission of comments on scientific guidelines
English (EN) (232 Ko - DOC)
Première publication:
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 Ko - XLSX)
Première publication:
Open consultations
Draft guideline on the clinical requirements for medicines intended for the treatment of sickle cell disease
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CHMP/HAEMWP/351950/2024
Summary:
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (362.77 Ko - PDF)
Première publication:
Draft guideline on the clinical requirements for medicines intended for the treatment of thalassaemia
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CHMP/HAEMWP/57392/2025
Summary:
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (431.62 Ko - PDF)
Première publication:
Draft guideline on user safety for pharmaceutical veterinary medicinal products - Revision 2
Draft: consultation open
Consultation dates:
to
Reference Number: EMEA/CVMP/543/03 Rev.2
Summary:
This revision replaces the previous version of the CVMP guideline on user safety for pharmaceutical veterinary medicinal products (EMEA/CVMP/543/03-Rev.1).
Comments should be provided using the template for comments.
English (EN) (450.28 Ko - PDF)
Première publication:
Draft guideline on veterinary good pharmacovigilance practices (VGVP) Module: Signal Management - Revision 1
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/522332/2021 Rev.1
Summary:
This guideline has been revised to reflect the current approach to the signal management process. The guideline provides general guidance on scientific and quality aspects of signal management for veterinary medicinal products (VMPs), and describes the roles, responsibilities and procedural aspects of the EU signal management process for VMPs.
Comments should be provided using this template. The completed comments form should be sent to vet-guidelines@ema.europa.eu
English (EN) (1.28 Mo - PDF)
Première publication:
Draft reflection paper on the clinical investigation of medicinal products for the treatment of systemic sclerosis
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/194597/2026
Summary:
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (446.96 Ko - PDF)
Première publication:
Concept paper on the revision of the CVMP guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances (EMA/CVMP/383441/2005-Rev.1 Corr.1)
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CVMP/AWP/381531/2025
Summary:
Comments should be provided using this template. The completed comments form should be sent to awpsecretariat@ema.europa.eu
English (EN) (201.29 Ko - PDF)
Première publication:
Draft guideline on the investigation of interactions in the gastrointestinal tract
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/136069/2026
Summary:
This guideline provides recommendations with regards to situations where the absorption of a drug from a medicinal product is altered by extrinsic factors in the gastrointestinal tract. Recommendations are provided on design, conduct and interpretation of in vitro and clinical absorption-related interaction studies. Treatment recommendations based on the clinical relevance of the interactions and the possibility to make dose adjustments or treatment monitoring are addressed.
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (324.22 Ko - PDF)
Première publication:
Draft guideline on clinical investigation of medicinal products for the treatment of migraine and cluster headache - Revision 2
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/137055/2026 Rev. 2
Summary:
This second revision aims to cover recommendations for the clinical development of medicinal products for the treatment of acute migraine attacks and for migraine prophylaxis in episodic and chronic migraine. In addition, recommendations for both acute and prophylactic treatment of episodic and chronic Cluster Headache are provided.
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (385.13 Ko - PDF)
Première publication:
Concept paper on the quality and safety aspects of RNA interference and RNA antisense oligonucleotide therapies as veterinary medicinal products
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CVMP/NTWP/24800/2026
Summary:
This concept paper addresses the need for a guideline on the quality and safety aspects of RNA interference and RNA antisense oligonucleotide therapies as veterinary medicinal products.
Comments should be provided using this template. The completed comments form should be sent to
vet-guidelines@ema.europa.eu
English (EN) (273.49 Ko - PDF)
Première publication:
Concept paper on the revision of the guideline on pharmaceutical fixed combination products (EMA/CVMP/83804/2005-Rev.1)
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CVMP/EWP/54206/2026
Summary:
The CVMP guideline on pharmaceutical fixed combination products (EMA/CVMP/83804/2005) was initially adopted in December 2006. The last revision (Rev.1) was carried out in July 2021, with the purpose to implement administrative changes to update the guideline with the new definitions and terminology provided by Article 4 of Regulation (EU) 2019/6.
This concept paper addresses the need for a more thorough revision of the guideline, in line with Regulation (EU) 2019/6, the European Commission’s Guidance to Applicants (C/2024/1443) and the CVMP guideline on the evaluation of the benefit-risk balance of veterinary medicinal products (EMA/CVMP/248499/2007-Rev.1). It also takes into consideration the experience gained in the assessment of data for fixed combination veterinary medicinal products. This experience has highlighted the need for further clarification and updating of certain aspects of the guideline to ensure alignment with current scientific knowledge and regulatory requirements.
Comments should be provided using this template. The completed comments form should be sent to
vet-guidelines@ema.europa.eu.
English (EN) (207.9 Ko - PDF)
Première publication:
Concept paper on revision of: Guideline on similar biological medicinal products, CHMP/437/04 Rev.1
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/CHMP/BMWP/153523/2026
Summary:
The proposed guideline will replace: Guideline on similar biological medicinal products (CHMP/437/04 Rev.1).
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (188.05 Ko - PDF)
Première publication:
Draft reflection paper on particulars for safety signals for (traditional) herbal medicinal products
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/HMPC/PRAC/301178/2025
Summary:
Comments should be provided using this template to hmpc.secretariat@ema.europa.eu
English (EN) (220.35 Ko - PDF)
Première publication:
Semaglutide and FlexTouch solution for injection in pre-filled pen product-specific bioequivalence guidance - various strengths
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/106257/2026
Summary:
The guidance covers the following products:
- Semaglutide, 0.25, 0.5, 1 and 2 mg solution for injection in pre-filled pen, 0.25, 0.5, 1, 1.7 and 2.4 mg solution for injection in pre-filled pen
- FlexTouch, 0.25, 0.5, 1, 1.7 and 2.4 mg solution for injection in pre-filled pen
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (161.3 Ko - PDF)
Première publication:
Guideline on the clinical evaluation of medicinal products for weight management - Addendum on weight control in children
Draft: consultation open
Consultation dates:
to
Reference Number: EMA/126591/2026
Summary:
Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.
English (EN) (288.5 Ko - PDF)
Première publication: