By EFORT Head Office |
The European Medicines Agency (EMA) has released for public consultation a draft guideline on the clinical development of medicinal products intended for the treatment of pain.
The Guideline is intended to provide guidance on the clinical development of new medicinal products for the treatment of pain.
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.
The present document should be considered as a general guidance. The main requirements for the development of medicinal products for the treatment of pain with regard to study design, patient population and outcome measures are described. Specific issues, including difficult to treat chronic pain patients and other specific patient groups (children and elderly) are addressed.
The document open for consultation is available in the EMA website.
Comments should be provided using the following Word template. The completed comments form should be sent to cnswpsecretariat@ema.europa.eu.
Please note that EFORT also invites you to share your comments in these guidelines in our EFORTnet forum. If you wish to contribute to the EFORT comments, please bring your feedback not later than the 21 March 2016.
Please note that the deadline for comments for this guideline is Thursday 31 March 2016.
More information:
- Draft guideline on the clinical development of medicinal products intended for the treatment of pain (PDF document, 28 pages, 264kb)
- Template for providing comments (Word document, 154kb)
- European Medicines Agency (EMA) Website
- EFORTnet – EFORT’s community platform and resource center | Create an account
- EFORTnet Forum – EMA draft guidelines comments
