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

Current effective version

Guideline on the clinical development of medicinal products intended for the treatment of pain - First version

Adopted Reference Number: EMA/CHMP/970057/2011 Legal effective date: 01/07/2017

Document history - First version (current)

Guideline on the clinical development of medicinal products intended for the treatment of pain - First version

Adopted Reference Number: EMA/CHMP/970057/2011 Legal effective date: 01/07/2017

Draft guideline on the clinical development of medicinal products intended for the treatment of pain - Second draft

Draft: consultation closed Consultation dates: 21/12/2015 to 31/03/2016 Reference Number: EMA/CHMP/970057/2011 Corr. Summary:

This guideline is intended to provide guidance on the clinical development of new medicinal products for the treatment of pain.

Draft guideline on the clinical development of medicinal products intended for the treatment of pain

Draft: consultation closed Consultation dates: 30/05/2013 to 30/11/2013 Reference Number: EMA/CHMP/970057/2011 Summary:

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.

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...

Draft: consultation closed Consultation dates: 22/09/2011 to 31/12/2011 Reference Number: EMA/CHMP/210477/2011 Summary:

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.

Superseded documents

Guideline on clinical medicinal products intended for the treatment of neuropathic pain

Adopted Reference Number: CPMP/EWP/252/03 Rev. 1 Legal effective date: 31/07/2007

Overview of comments received on draft guideline on clinical medicinal products intended for the treatment of neuropathic pain

Reference Number: EMEA/CHMP/EWP/21568/2007

Draft guideline on clinical medicinal products intended for the treatment of neuropathic pain

Draft: consultation closed Reference Number: CPMP/EWP/252/03 Rev. 1

Note for guidance on clinical investigation of medicinal products for treatment of nociceptive pain

Adopted Reference Number: CPMP/EWP/612/00 Legal effective date: 01/05/2003