Evaluation of anticancer medicinal products in man - Scientific guideline
Table of contents
The proposed guideline will replace 'guideline on the evaluation of anticancer medicinal products in man' (EMA/CHMP/205/95 Rev.5)
Keywords: Cancer, malignancy, biomarker, targeted drugs, pharmacogenomics
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Draft guideline on the evaluation of anticancer medicinal products in man - Revision 6 (PDF/538.16 KB)
Draft: consultation closed
First published: 16/11/2020
Consultation dates: 13/11/2020 to 15/02/2021
EMA/CHMP/205/95 Rev.6 -
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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/162.65 KB)
Adopted
First published: 24/05/2022
Legal effective date: 23/05/2022
EMA/631612/2021 -
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Draft 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: consultation closed
First published: 16/11/2020
Consultation dates: 13/11/2020 to 15/02/2021
EMA/593364/2020
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Concept paper on the revision of the guideline on the evaluation of anticancer medicinal products in man (PDF/87.63 KB)
Draft: consultation closed
First published: 14/01/2019
Consultation dates: 14/01/2019 to 14/04/2019
EMA/CHMP/755489/2018 -
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Guideline on the evaluation of anticancer medicinal products in man - Revision 5 (PDF/381.64 KB)
Adopted
First published: 20/11/2017
Last updated: 20/11/2017
Legal effective date: 01/04/2018
EMA/CHMP/205/95 Rev. 5 -
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Draft guideline on evaluation of anticancer medicinal products in man - Revision 5 (PDF/387.48 KB)
Draft: consultation closed
First published: 15/03/2016
Last updated: 15/03/2016
Consultation dates: 15/03/2016 to 15/09/2016
EMA/CHMP/205/95 Rev. 5 -
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Draft concept paper on the need to revise the "Guideline on the evaluation of anticancer medicinal products in man" in order to provide guidance on the reporting of safety data from clinical trials - Revision 5 (PDF/108.46 KB)
Draft: consultation closed
First published: 30/04/2015
Last updated: 30/04/2015
Consultation dates: 01/05/2015 to 31/07/2015
EMA/130525/2015 Rev. 5 -
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Guideline on the evaluation of anticancer medicinal products in man - Revision 4 (PDF/354.33 KB)
Adopted
First published: 11/01/2013
Last updated: 11/01/2013
Legal effective date: 01/07/2013
EMA/CHMP/205/95 Rev. 4 -
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Draft guideline on the evaluation of anticancer medicinal products in man - Revision 4 (PDF/252.47 KB)
Draft: consultation closed
First published: 22/12/2011
Last updated: 22/12/2011
Consultation dates: 15/12/2011 to 31/05/2012
EMA/CHMP/205/95 Rev.4 -
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Concept paper on the need to revise the guideline on the evaluation of anticancer medicinal products in man - Revision 4 (PDF/64.04 KB)
Draft: consultation closed
First published: 17/09/2010
Last updated: 17/09/2010
Consultation dates: 22/07/2010 to 01/01/2011
EMA/CHMP/EWP/433478/2010 Rev. 4 -
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Guideline on the evaluation of anticancer medicinal products in man - Revision 3 (PDF/170.12 KB)
Adopted
First published: 14/12/2005
Last updated: 14/12/2005
Legal effective date: 01/06/2006
CPMP/EWP/205/95/Rev.3/Corr.2
- Clinical efficacy and safety: antineoplastic and immunomodulating agents
- Appendix 1 to the guideline on the evaluation of anticancer medicinal products in man: methodological consideration for using progression-free survival (PFS) or disease-free survival (DFS) in confirmatory trials
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Appendix 2 to the guideline on the evaluation of anticancer medicinal products in man: use of patient-reported outcome (PRO) measures in oncology studies
- Appendix 4 to the guideline on the evaluation of anticancer medicinal products in man: condition specific guidance
- Directive 2001/83/EC
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Qualification of novel methodologies for drug development: guidance to applicants
- Addendum on paediatric oncology to the note for guidance on evaluation of anticancer medicinal products in man (revision in progress)
- Adjustment for baseline covariates in clinical trials
- Application with 1. Meta-analyses; 2. One pivotal study
- Choice of a non-inferiority margin
- Clinical evaluation of diagnostic agents
- Clinical investigation of the pharmacokinetics of therapeutic proteins
- Clinical trials in small populations
- Evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic function
- ICH E2A Clinical safety data management: definitions and standards for expedited reporting
- ICH E10 Choice of control group in clinical trials
- ICH S9 Non-clinical evaluation for anticancer pharmaceuticals
- Investigation of drug interactions
- Methodological issues in confirmatory clinical trials planned with an adaptive design
- Methodological issues with pharmacogenomic biomarkers in relation to clinical development and patient selection
- Multiplicity issues in clinical trials
- Pharmaceutical development of medicines for paediatric use
- Pharmacogenomics in oncology