Open consultations

23/11/2020 - Palbociclib hard capsule 75 mg, 100 mg and 125 mg and film-coated tablet 75 mg, 100 mg and 125 mg product-specific bioequivalence guidance - Revision 1

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Palbociclib hard capsule 75 mg, 100 mg and 125 mg and film-coated tablet 75 mg, 100 mg and 125 mg product-specific bioequivalence guidance - Revision 1 (PDF/160.42 KB)

Reference number

EMA/CHMP/472421/2020/Rev. 1

Status

Draft: consultation open

First published

23/11/2020

Consultation dates

23/11/2020 to 28/02/2021

Email address for submissions

PKWPsecretariat@ema.europa.eu

Summary

Palbociclib hard capsule 75 mg, 100 mg and 125 mg and film-coated tablet 75 mg, 100 mg and 125 mg product-specific bioequivalence guidance

16/11/2020 - Draft guideline on the evaluation of anticancer medicinal products in man - Revision 6

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Draft guideline on the evaluation of anticancer medicinal products in man - Revision 6 (PDF/538.16 KB)

Reference number

EMA/CHMP/205/95 Rev.6

Status

Draft: consultation open

First published

16/11/2020

Consultation dates

13/11/2020 to 15/02/2021

Email address for submissions

ONCWP@ema.europa.eu

16/11/2020 - Appendix 3 to the guideline on the clinical evaluation of anticancer medicinal products - Summary of Product Characteristics for an Anticancer medicinal product – mock-up of 4.8

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Appendix 3 to the guideline on the clinical evaluation of anticancer medicinal products - Summary of Product Characteristics for an Anticancer medicinal product – mock-up of 4.8 (PDF/171.44 KB)

Reference number

EMA/593364/2020

Status

Draft: consultation open

First published

16/11/2020

Consultation dates

13/11/2020 to 15/02/2021

12/11/2020 - Draft concept paper on the reporting of antimicrobial sales and use in animals at the EU level

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Draft concept paper on the reporting of antimicrobial sales and use in animals at the EU level (PDF/124.88 KB)

Reference number

EMA/222040/2020

Status

Draft: consultation open

First published

12/11/2020

Consultation dates

12/11/2020 to 31/01/2021

Email address for submissions

vet_guidelines@ema.europa.eu

09/11/2020 - Draft acenocoumarol, tablet, 1 mg and 4 mg product-specific bioequivalence guidance - First version

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Draft acenocoumarol, tablet, 1 mg and 4 mg product-specific bioequivalence guidance - First version (PDF/139.48 KB)

Reference number

EMA/CHMP/512475/2020

Status

Draft: consultation open

First published

09/11/2020

Consultation dates

09/11/2020 to 28/02/2021

Email address for submissions

PKWP@ema.europa.eu

13/10/2020 - Draft guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg) - Rev. 6

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Draft guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg) - Rev. 6 (PDF/528.75 KB)

Reference number

EMA/CHMP/BPWP/94038/2007 Rev. 6

Status

Draft: consultation open

First published

13/10/2020

Consultation dates

13/10/2020 to 13/01/2021

13/10/2020 - Draft guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) - Rev. 4

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Draft guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) - Rev. 4 (PDF/359.27 KB)

Reference number

EMA/CHMP/BPWP/94033/2007 Rev.4

Status

Draft: consultation open

First published

13/10/2020

Consultation dates

13/10/2020 to 13/01/2021

24/09/2020 - Guideline on registry-based studies

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Guideline on registry-based studies (PDF/685.43 KB)

Reference number

EMA/502388/2020

Status

Draft: consultation open

First published

24/09/2020

Consultation dates

24/09/2020 to 31/12/2020

Email address for submissions

EMAregistries@ema.europa.eu

Summary

The guideline was developed based on the comments received on the discussion paper on ‘Methodological and operational considerations on the use of patient disease registries for regulatory purposes’, that went through a public consultation between November 2018 and June 2019, and a consultation of EMA Committees and Working parties.

18/09/2020 - Draft ICH guideline Q3D (R2) on elemental impurities - Step 2b

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Draft ICH guideline Q3D (R2) on elemental impurities - Step 2b (PDF/369.09 KB)

Reference number

EMA/CHMP/ICH/353369/2013

Status

Draft: consultation open

First published

18/09/2020

Last updated

01/10/2020

Consultation dates

18/09/2020 to 25/12/2020

Email address for submissions

ich@ema.europa.eu

Summary

Public consultation of the ICH guideline Q3D (R2) on elemental impurities - Step 2b

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/149.33 KB)

Reference number

EMA/CHMP/257298/2018

Status

Draft: consultation open

First published

03/07/2020

Last updated

17/11/2020

Consultation dates

06/07/2020 to 31/01/2021

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.

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)

Topics

Palbociclib hard capsule 75 mg, 100 mg and 125 mg and film-coated tablet 75 mg, 100 mg and 125 mg product-specific bioequivalence guidance - Revision 1 (PDF/160.42 KB)

Draft guideline on the evaluation of anticancer medicinal products in man - Revision 6 (PDF/538.16 KB)

Appendix 3 to the guideline on the clinical evaluation of anticancer medicinal products - Summary of Product Characteristics for an Anticancer medicinal product – mock-up of 4.8 (PDF/171.44 KB)

Draft concept paper on the reporting of antimicrobial sales and use in animals at the EU level (PDF/124.88 KB)

Draft acenocoumarol, tablet, 1 mg and 4 mg product-specific bioequivalence guidance - First version (PDF/139.48 KB)

Draft guideline on core SmPC for human normal immunoglobulin for intravenous administration (IVIg) - Rev. 6 (PDF/528.75 KB)

Draft guideline on the clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) - Rev. 4 (PDF/359.27 KB)

Guideline on registry-based studies (PDF/685.43 KB)

Draft ICH guideline Q3D (R2) on elemental impurities - Step 2b (PDF/369.09 KB)

Draft 2 - Lapatinib film-coated tablet 250 mg product-specific bioequivalence guidance (PDF/149.33 KB)

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