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

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 (CPMP/EWP/252/03) and nociceptive pain (CPMP/EWP/612/00). Pain syndromes have traditionally been divided into the aforementioned two categories of neuropathic and nociceptive pain, based on what seemed to be a clear mechanistic distinction. Many pain conditions can still be defined in such terms but in other cases, for chronic pain in particular, the distinction is not clear and this needs to be reflected in diagnostic, therapeutic and regulatory approaches.


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