Open consultations

06/07/2020 - European medicines agencies network strategy to 2025: Protecting public health at a time of rapid change

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European medicines agencies network strategy to 2025: Protecting public health at a time of rapid change (PDF/610.64 KB)

Reference number

EMA/321483/2020

Status

Draft: consultation open

First published

06/07/2020

Consultation dates

06/07/2020 to 04/09/2020

Summary

Input on the draft strategy document is welcome from all stakeholders, including members of the public, until 4 September 2020 via an online questionnaire.

03/07/2020 - Questions and answers - ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Step 2b

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Questions and answers - ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Step 2b (PDF/403.88 KB)

Reference number

EMA/CHMP/ICH/321999/2020

Status

Draft: consultation open

First published

03/07/2020

Consultation dates

03/07/2020 to 02/10/2020

Summary

This question and answer (Q&A) document aims to provide additional clarification and to promote convergence and harmonisation of the considerations for assessment and control of DNA reactive (mutagenic) impurities and of the information provided during drug development, marketing authorisation applications and/or master files.

The scope of this Q&A document follows that of ICH M7.
Use the comments form to provide comments. The completed comments form should be sent to ich@ema.europa.eu.

03/07/2020 - Draft 2 Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance

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Draft 2 Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance (PDF/165.08 KB)

Reference number

EMA/CHMP/257298/2018

Status

Draft: consultation open

First published

03/07/2020

Consultation dates

01/07/2020 to 30/09/2020

Email address for submissions

PKWPsecretariat@ema.europa.eu

Summary

This document provides product-specific guidance on the demonstration of the bioequivalence of lapatinib film-coated tablet 250 mg. This is the second public consultation after significant revision of the draft requirements in response to the comments from the first public consultation.

01/07/2020 - CVMP strategy on antimicrobials 2021-2025

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CVMP strategy on antimicrobials 2021-2025 (PDF/325.1 KB)

Reference number

EMA/CVMP/179874/2020

Status

Draft: consultation open

First published

01/07/2020

Consultation dates

01/07/2020 to 30/09/2020

Email address for submissions

vet-guidelines@ema.europa.eu

Summary

The CVMP’s draft strategy on antimicrobials for the period from 2021 to 2025 is now published for public consultation until 30 September 2020. The focus of the CVMP’s activities will be on supporting the effective implementation of those provisions in the Regulation (EU) 2019/6 that take forward the EU’s One Health Action Plan against antimicrobial resistance (AMR).

15/06/2020 - Draft abiraterone tablets 250 mg and 500 mg product-specific bioequivalence guidance

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Draft abiraterone tablets 250 mg and 500 mg product-specific bioequivalence guidance (PDF/165.92 KB)

Reference number

EMA/CHMP/474712/2016 Rev. 1

Status

Draft: consultation open

First published

15/06/2020

Consultation dates

15/06/2020 to 30/09/2020

Email address for submissions

PKWPsecretariat@ema.europa.eu

15/06/2020 - Levothyroxine tablets 12.5 mcg, 25 mcg, 50 mcg, 75 mcg, 100 mcg (and additional strengths) and 200 mcg product-specific bioequivalence guidance

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Levothyroxine tablets 12.5 mcg, 25 mcg, 50 mcg, 75 mcg, 100 mcg (and additional strengths) and 200 mcg product-specific bioequivalence guidance (PDF/159.16 KB)

Reference number

EMA/CHMP/176098/2020

Status

Draft: consultation open

First published

15/06/2020

Consultation dates

15/06/2020 to 30/09/2020

Email address for submissions

PKWPsecretariat@ema.europa.eu

Summary

This document provides product-specific guidance on the demonstration of the bioequivalence of levothyroxine.

29/05/2020 - Draft European Union herbal monograph on Aloysia citrodora Paláu (syn. Aloysia triphylla (L'Hér.) Kuntze; Verbena triphylla L'Hér.; Lippia citriodora Kunth), folium

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Draft European Union herbal monograph on Aloysia citrodora Paláu (syn. Aloysia triphylla (L'Hér.) Kuntze; Verbena triphylla L'Hér.; Lippia citriodora Kunth), folium (PDF/207.88 KB)

Reference number

EMA/HMPC/376770/2019

Status

Draft: consultation open

First published

29/05/2020

Consultation dates

31/05/2020 to 31/08/2020

Email address for submissions

hmpc.secretariat@ema.europa.eu

29/05/2020 - Draft European Union herbal monograph on Species sedativae

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Draft European Union herbal monograph on Species sedativae (PDF/216.12 KB)

Reference number

EMA/HMPC/438183/2017

Status

Draft: consultation open

First published

29/05/2020

Consultation dates

31/05/2020 to 31/08/2020

Email address for submissions

hmpc.secretariat@ema.europa.eu

07/05/2020 - Concept paper for the development of a reflection paper on the environmental risk assessment for parasiticide veterinary medicinal products used in companion animals

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Concept paper for the development of a reflection paper on the environmental risk assessment for parasiticide veterinary medicinal products used in companion animals (PDF/175.62 KB)

Reference number

EMA/CVMP/ERA/55512/2020

Status

Draft: consultation open

First published

07/05/2020

Consultation dates

07/05/2020 to 31/10/2020

Email address for submissions

vet-guidelines@ema.europa.eu

06/05/2020 - Dasatinib film-coated tablets 20, 50, 70, 80, 100 & 140 mg and suspension 10 mg/ml product-specific bioequivalence guidance

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Dasatinib film-coated tablets 20, 50, 70, 80, 100 & 140 mg and suspension 10 mg/ml product-specific bioequivalence guidance (PDF/232.55 KB)

Reference number

EMA/CHMP/675838/2014/Rev. 1

Status

Draft: consultation open

First published

06/05/2020

Consultation dates

04/05/2020 to 31/08/2020

Email address for submissions

PKWP@ema.europa.eu

Summary

Revision 1 of the guideline on dasatinib film-coated tablets 20, 50, 70, 80, 100 & 140 mg and suspension 10 mg/ml product-specific bioequivalence.
This revision concerns the additional requirement for a fed study and the requirements for a suspension.

04/05/2020 - Q3C (R8) Step 2b - impurities guideline for residual solvents - Pde for 2-methyltetrahydrofuran, cyclopentyl methyl ether, and tertiary-butyl alcohol

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Q3C (R8) Step 2b - impurities guideline for residual solvents - Pde for 2-methyltetrahydrofuran, cyclopentyl methyl ether, and tertiary-butyl alcohol (PDF/379.63 KB)

Reference number

EMA/CHMP/ICH/213867/2020

Status

Draft: consultation open

First published

04/05/2020

Consultation dates

04/05/2020 to 30/07/2020

Email address for submissions

ich@ema.europa.eu

31/01/2020 - Call for scientific data for the periodic review of the monograph on Agropyron repens (L.) P. Beauv., rhizoma - Revision 1

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Call for scientific data for the periodic review of the monograph on Agropyron repens (L.) P. Beauv., rhizoma - Revision 1 (PDF/83.07 KB)

Reference number

EMA/HMPC/47033/2020

Status

Draft: consultation open

First published

31/01/2020

20/01/2020 - Reflection paper on good manufacturing practice and marketing authorisation holders

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Reflection paper on good manufacturing practice and marketing authorisation holders (PDF/469.04 KB)

Reference number

EMA/457570/2019

Status

Draft: consultation open

First published

20/01/2020

Last updated

29/04/2020

Consultation dates

17/01/2020 to 17/07/2020

Email address for submissions

adm-gmdp@ema.europa.eu

Summary

Deadline for comments comments has been extended to 17/07/2020.

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

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

European medicines agencies network strategy to 2025: Protecting public health at a time of rapid change (PDF/610.64 KB)

Questions and answers - ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Step 2b (PDF/403.88 KB)

Draft 2 Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance (PDF/165.08 KB)

CVMP strategy on antimicrobials 2021-2025 (PDF/325.1 KB)

Draft abiraterone tablets 250 mg and 500 mg product-specific bioequivalence guidance (PDF/165.92 KB)

Levothyroxine tablets 12.5 mcg, 25 mcg, 50 mcg, 75 mcg, 100 mcg (and additional strengths) and 200 mcg product-specific bioequivalence guidance (PDF/159.16 KB)

Draft European Union herbal monograph on Aloysia citrodora Paláu (syn. Aloysia triphylla (L'Hér.) Kuntze; Verbena triphylla L'Hér.; Lippia citriodora Kunth), folium (PDF/207.88 KB)

Draft European Union herbal monograph on Species sedativae (PDF/216.12 KB)

Concept paper for the development of a reflection paper on the environmental risk assessment for parasiticide veterinary medicinal products used in companion animals (PDF/175.62 KB)

Dasatinib film-coated tablets 20, 50, 70, 80, 100 & 140 mg and suspension 10 mg/ml product-specific bioequivalence guidance (PDF/232.55 KB)

Q3C (R8) Step 2b - impurities guideline for residual solvents - Pde for 2-methyltetrahydrofuran, cyclopentyl methyl ether, and tertiary-butyl alcohol (PDF/379.63 KB)

Call for scientific data for the periodic review of the monograph on Agropyron repens (L.) P. Beauv., rhizoma - Revision 1 (PDF/83.07 KB)

Reflection paper on good manufacturing practice and marketing authorisation holders (PDF/469.04 KB)

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