EMA has just released, for consultation, a new concept paper on the revision of the guidelines on the development of new medicinal products for the treatment of chronic constipation. Consultation ends on 15 February 2013.
The development of medicinal products influencing gut transit and defecation is one of the oldest principles of pharmacological treatment. Numerous products have been introduced into the market even at times before drug regulation laws came into force within Europe. Nevertheless, the requirements for drug approval in this setting have never been laid down before, and the analysis of the data in support of many commonly used substances in the field have revealed that there is only insufficient evidence available to adequately support efficacy and safety of many of these substances.