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
Current effective version
Guideline on the clinical development of medicinal products intended for the treatment of pain - First version
English (EN) (246.33 KB - PDF)
Document history - First version (current)
Guideline on the clinical development of medicinal products intended for the treatment of pain - First version
English (EN) (246.33 KB - PDF)
Draft guideline on the clinical development of medicinal products intended for the treatment of pain - Second draft
This guideline is intended to provide guidance on the clinical development of new medicinal products for the treatment of pain.
English (EN) (274.13 KB - PDF)
Draft guideline on the clinical development of medicinal products intended for the treatment of pain
This document is intended to give guidance on the investigation of medicinal products to be used in the treatment of nociceptive pain and / or of central and peripheral neuropathic pain.
English (EN) (398.48 KB - PDF)
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...
The proposed guideline will replace guideline CPMP/EWP/612/00-Note for Guidance on Clinical Investigation of Medicinal Products for Treatment of Nociceptive Pain and the CHMP/EWP/252/03-Guideline on clinical investigation of medicinal products intended for the treatment of neuropathic pain.
English (EN) (88.71 KB - PDF)
Superseded documents
Guideline on clinical medicinal products intended for the treatment of neuropathic pain
English (EN) (108.46 KB - PDF)
Overview of comments received on draft guideline on clinical medicinal products intended for the treatment of neuropathic pain
English (EN) (46.46 KB - PDF)
Draft guideline on clinical medicinal products intended for the treatment of neuropathic pain
English (EN) (119.46 KB - PDF)
Note for guidance on clinical investigation of medicinal products for treatment of nociceptive pain
English (EN) (183.36 KB - PDF)
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