Clinical development of medicinal products intended for the treatment of pain - Scientific guideline
This guideline is intended to provide guidance on the clinical development of new medicinal products for the treatment of pain. It replaces and updates the separate guidelines on neuropathic and nociceptive pain (superseeded documents below).
Keywords: Pain, neuropathic, nociceptive, chronic, acute, analgesia
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Guideline on the clinical development of medicinal products intended for the treatment of pain - First version (PDF/246.33 KB)
Adopted
First published: 22/12/2016
Last updated: 22/12/2016
Legal effective date: 01/07/2017
EMA/CHMP/970057/2011 -
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Draft guideline on the clinical development of medicinal products intended for the treatment of pain - Second draft (PDF/274.13 KB)
Draft: consultation closed
First published: 21/12/2015
Last updated: 21/12/2015
Consultation dates: 21/12/2015 to 31/03/2016
EMA/CHMP/970057/2011 Corr. -
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Draft guideline on the clinical development of medicinal products intended for the treatment of pain (PDF/398.48 KB)
Draft: consultation closed
First published: 30/05/2013
Last updated: 30/05/2013
Consultation dates: 30/05/2013 to 30/11/2013
EMA/CHMP/970057/2011 -
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Concept paper on the need for revision of note for guidance on clinical medicinal products for treatment of nociceptive pain and guideline on clinical investigation of products intended for the treatment of neuropathic p... (PDF/88.71 KB)
Draft: consultation closed
First published: 29/09/2011
Last updated: 29/09/2011
Consultation dates: 22/09/2011 to 31/12/2011
EMA/CHMP/210477/2011
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Guideline on clinical medicinal products intended for the treatment of neuropathic pain (PDF/108.46 KB)
Adopted
First published: 24/01/2007
Last updated: 24/01/2007
Legal effective date: 31/07/2007
CPMP/EWP/252/03 Rev. 1 -
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Overview of comments received on draft guideline on clinical medicinal products intended for the treatment of neuropathic pain (PDF/46.46 KB)
First published: 24/01/2007
Last updated: 24/01/2007
EMEA/CHMP/EWP/21568/2007 -
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Draft guideline on clinical medicinal products intended for the treatment of neuropathic pain (PDF/119.46 KB)
Draft: consultation closed
First published: 26/01/2006
Last updated: 26/01/2006
CPMP/EWP/252/03 Rev. 1 -
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Note for guidance on clinical investigation of medicinal products for treatment of nociceptive pain (PDF/183.36 KB)
Adopted
First published: 21/11/2002
Last updated: 21/11/2002
Legal effective date: 01/05/2003
CPMP/EWP/612/00
- Clinical efficacy and safety: nervous system
- Directive 2001/83/EC
- Adjustment for baseline covariates in clinical trials
- Choice of the non-inferiority margin
- Clinical development of fixed combination medicinal products
- Clinical investigation of medicinal products for the treatment of migraine
- Clinical investigation of medicinal products used in the treatment of osteoarthritis
- Clinical requirements for locally applied locally acting products containing known constituents
- Extrapolation of results from clinical studies conducted outside the EU to the EU population
- ICH E1 Extent of population exposure to assess clinical safety
- ICH E4 Dose-response information to support drug registration
- ICH E6 (R1) Good clinical practice
- ICH E7 Studies in support of special populations: geriatrics
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Questions and answers on the ICH E7 guideline on the studies in support of special populations: geriatrics
- ICH E8 General Considerations for Clinical Trials
- ICH E9 Statistical principles for clinical trials
- ICH E10 Choice of control group in clinical trials
- ICH E11 Clinical investigation of medicinal products in the paediatric population
- Investigation of drug interactions
- Missing data in confirmatory clinical trials
- Non-clinical investigation of the dependence potential of medicinal products
- Pharmacokinetic studies in man
- Quality of transdermal patches
- Role of pharmacokinetics in the development of medicinal products in the paediatric population