Open consultations

31/03/2023 - Call for scientific data for the periodic review of the monograph on Fragariae folium - Revision 1

List item

Call for scientific data for the periodic review of the monograph on Fragariae folium - Revision 1 (PDF/122.03 KB)

Reference number

EMA/HMPC/140986/2023

Status

Draft: consultation open

First published

31/03/2023

31/03/2023 - Guideline on Quality Aspects of Pharmaceutical Veterinary Medicines for administration via drinking water - Draft Annex on compatibility studies between veterinary medicinal products and biocidal products

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Guideline on Quality Aspects of Pharmaceutical Veterinary Medicines for administration via drinking water - Draft Annex on compatibility studies between veterinary medicinal products and biocidal products (PDF/213.81 KB)

Reference number

EMA/CVMP/QWP/592906/2022

Status

Draft: consultation open

First published

31/03/2023

Consultation dates

01/04/2023 to 30/06/2023

Email address for submissions

vet-guidelines@ema.europa.eu

31/03/2023 - Call for scientific data for the periodic review of the monograph on Malvae folium

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Call for scientific data for the periodic review of the monograph on Malvae folium (PDF/120.99 KB)

Reference number

EMA/HMPC/141175/2023

Status

Draft: consultation open

First published

31/03/2023

Consultation dates

31/03/2023 to 30/06/2023

Email address for submissions

hmpc.secretariat@ema.europa.eu

31/03/2023 - Call for scientific data for the periodic review of the monograph on Malvae sylvestris flos

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Call for scientific data for the periodic review of the monograph on Malvae sylvestris flos (PDF/120.4 KB)

Reference number

EMA/HMPC/141161/2023

Status

Draft: consultation open

First published

31/03/2023

Consultation dates

31/03/2023 to 30/06/2023

Email address for submissions

hmpc.secretariat@ema.europa.eu

31/03/2023 - Call for scientific data for the periodic review of the monograph on Soiae oleum raffinatum

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Call for scientific data for the periodic review of the monograph on Soiae oleum raffinatum (PDF/120.75 KB)

Reference number

EMA/HMPC/141196/2023

Status

Draft: consultation open

First published

31/03/2023

Consultation dates

31/03/2023 to 30/06/2023

Email address for submissions

hmpc.secretariat@ema.europa.eu

31/03/2023 - Call for scientific data for the periodic review of the monograph on Matricariae aetheroleum

List item

Call for scientific data for the periodic review of the monograph on Matricariae aetheroleum (PDF/120.4 KB)

Reference number

EMA/HMPC/141099/2023

Status

Draft: consultation open

First published

31/03/2023

Consultation dates

31/03/2023 to 30/06/2023

Email address for submissions

hmpc.secretariat@ema.europa.eu

31/03/2023 - Call for scientific data for the periodic review of the monograph on Lecithinum ex soya - Revision 1

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Call for scientific data for the periodic review of the monograph on Lecithinum ex soya - Revision 1 (PDF/120.41 KB)

Reference number

EMA/HMPC/141083/2023

Status

Draft: consultation open

First published

31/03/2023

Consultation dates

31/03/2023 to 30/06/2023

31/03/2023 - Call for scientific data for the periodic review of the monograph on Fragariae folium - Revision 1

List item

Call for scientific data for the periodic review of the monograph on Fragariae folium - Revision 1 (PDF/122.03 KB)

Reference number

EMA/HMPC/140986/2023

Status

Draft: consultation open

First published

31/03/2023

Consultation dates

31/03/2023 to 30/06/2023

01/03/2023 - Draft Qualification Opinion for Stride velocity 95th centile as primary endpoint in studies in ambulatory Duchenne Muscular Dystrophy

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Draft Qualification Opinion for Stride velocity 95th centile as primary endpoint in studies in ambulatory Duchenne Muscular Dystrophy (PDF/3.88 MB)

Status

Draft: consultation open

First published

01/03/2023

Consultation dates

28/02/2023 to 10/04/2023

Email address for submissions

ScientificAdvice@ema.europa.eu

24/02/2023 - Guideline on plasmid DNA vaccines for veterinary use

List item

Guideline on plasmid DNA vaccines for veterinary use (PDF/200.57 KB)

Reference number

EMA/CVMP/IWP/365817/2022

Status

Draft: consultation open

First published

24/02/2023

Consultation dates

24/02/2023 to 23/06/2023

15/02/2023 - Call for scientific data for use in HMPC assessment work on herbal tea combinations traditionally used in the therapeutic area ‘cough and cold’

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Call for scientific data for use in HMPC assessment work on herbal tea combinations traditionally used in the therapeutic area ‘cough and cold’ (PDF/110.25 KB)

Reference number

EMA/HMPC/68490/2023

Status

Draft: consultation open

First published

15/02/2023

Consultation dates

15/02/2023 to 14/05/2023

Email address for submissions

hmpc.secretariat@ema.europa.eu

15/02/2023 - Call for scientific data for the use in HMPC assessment work on Pruni cerasi stipites

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Call for scientific data for the use in HMPC assessment work on Pruni cerasi stipites (PDF/119.2 KB)

Reference number

EMA/HMPC/68488/2023

Status

Draft: consultation open

First published

15/02/2023

Consultation dates

15/02/2023 to 14/05/2023

Email address for submissions

hmpc.secretariat@ema.europa.eu

15/02/2023 - Call for scientific data for use in HMPC assessment work on Cannabis sativa L., flos (Cannabis sativa flowering tops)

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Call for scientific data for use in HMPC assessment work on Cannabis sativa L., flos (Cannabis sativa flowering tops) (PDF/248.35 KB)

Reference number

EMA/HMPC/697513/2022

Status

Draft: consultation open

First published

15/02/2023

Consultation dates

15/02/2023 to 14/05/2023

Email address for submissions

hmpc.secretariat@ema.europa.eu

14/02/2023 - Concept paper on revision of the ‘Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products / traditional herbal medicinal products’

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Concept paper on revision of the ‘Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products / traditional herbal medicinal products’ (PDF/198.64 KB)

Reference number

EMA/HMPC/888811/2022

Status

Draft: consultation open

First published

14/02/2023

Consultation dates

01/03/2023 to 31/05/2023

Email address for submissions

hmpc.secretariat@ema.europa.eu

07/02/2023 - ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms - Step 2b

List item

ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms - Step 2b (PDF/970.26 KB)

Reference number

EMA/CHMP/ICH953493/2022

Status

Draft: consultation open

First published

07/02/2023

Consultation dates

26/01/2023 to 26/05/2023

Email address for submissions

ich@ema.europa.eu

27/01/2023 - Guideline on quality, safety and efficacy of veterinary 5 medicinal products specifically designed for phage 6 therapy

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Guideline on quality, safety and efficacy of veterinary 5 medicinal products specifically designed for phage 6 therapy (PDF/533.1 KB)

Reference number

EMA/CVMP/NTWP/32862/2022

Status

Draft: consultation open

First published

27/01/2023

Consultation dates

27/01/2023 to 31/05/2023

18/11/2022 - Reflection paper on the criteria to be considered for the evaluation of new active substance (NAS) status of biological substances

List item

Reflection paper on the criteria to be considered for the evaluation of new active substance (NAS) status of biological substances (PDF/342.83 KB)

Reference number

EMA/CHMP/CMDh/CAT/BWP/828612/2022

Status

Draft: consultation open

First published

18/11/2022

Consultation dates

18/11/2022 to 31/05/2023

Email address for submissions

BWPsecretariat@ema.europa.eu

Summary

This reflection paper is intended to reflect the current experience of the Biologics Working Party (BWP) of the Committee for Medicinal Products for Human Use (CHMP), the Committee for Advanced Therapies (CAT), and the Co-ordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh) on New Active Substance (NAS) in the context of scientific advice and assessment of Marketing Authorisation Applications (MAA).
It applies to all types of procedures for submission of a MAA, i.e. Centralised Procedure (CP), Mutual Recognition Procedure (MRP)/Decentralised Procedure (DCP) and purely national procedures for biological and biotechnology-derived medicinal products for human use.

05/07/2021 - Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Glossary

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Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Glossary (PDF/162.95 KB)

Reference number

EMA/118227/2021

Status

Draft: consultation open

First published

05/07/2021

Email address for submissions

Vet-Guidelines@ema.europa.eu

Form for submission of comments on scientific guidelines (DOC/232 KB)

Submission of comments on ICH guidelines (XLSX/208.69 KB)

European Medicines Agency’s privacy statement public and targeted consultations (PDF/134.32 KB)

Call for scientific data for the periodic review of the monograph on Fragariae folium - Revision 1 (PDF/122.03 KB)

Guideline on Quality Aspects of Pharmaceutical Veterinary Medicines for administration via drinking water - Draft Annex on compatibility studies between veterinary medicinal products and biocidal products (PDF/213.81 KB)

Call for scientific data for the periodic review of the monograph on Malvae folium (PDF/120.99 KB)

Call for scientific data for the periodic review of the monograph on Malvae sylvestris flos (PDF/120.4 KB)

Call for scientific data for the periodic review of the monograph on Soiae oleum raffinatum (PDF/120.75 KB)

Call for scientific data for the periodic review of the monograph on Matricariae aetheroleum (PDF/120.4 KB)

Call for scientific data for the periodic review of the monograph on Lecithinum ex soya - Revision 1 (PDF/120.41 KB)

Call for scientific data for the periodic review of the monograph on Fragariae folium - Revision 1 (PDF/122.03 KB)

Draft Qualification Opinion for Stride velocity 95th centile as primary endpoint in studies in ambulatory Duchenne Muscular Dystrophy (PDF/3.88 MB)

Guideline on plasmid DNA vaccines for veterinary use (PDF/200.57 KB)

Call for scientific data for use in HMPC assessment work on herbal tea combinations traditionally used in the therapeutic area ‘cough and cold’ (PDF/110.25 KB)

Call for scientific data for the use in HMPC assessment work on Pruni cerasi stipites (PDF/119.2 KB)

Call for scientific data for use in HMPC assessment work on Cannabis sativa L., flos (Cannabis sativa flowering tops) (PDF/248.35 KB)

Concept paper on revision of the ‘Guideline on declaration of herbal substances and herbal preparations in herbal medicinal products / traditional herbal medicinal products’ (PDF/198.64 KB)

ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms - Step 2b (PDF/970.26 KB)

Guideline on quality, safety and efficacy of veterinary 5 medicinal products specifically designed for phage 6 therapy (PDF/533.1 KB)

Reflection paper on the criteria to be considered for the evaluation of new active substance (NAS) status of biological substances (PDF/342.83 KB)

Draft guideline on veterinary good pharmacovigilance practices (VGVP) - Module: Glossary (PDF/162.95 KB)

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