Regulatory Focus™ > News Articles > EMA Wants Harmonized Guideline for IBS Medications

EMA Wants Harmonized Guideline for IBS Medications

Posted 11 June 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) wants better medicinal products to treat irritable bowel syndrome. The disorder, which affects an estimated 20% of the population of western countries by the agency's estimation, is poorly understood and lacks adequate treatment options.

Regulators released a "points to consider" (PtC) document in 2003 in an attempt to outline the clinical issues surrounding the development of IBS medications, but it has since then gone without an update. EMA said in an announcement on 8 June that it hopes to bring the PtC document up to date this year, and released a concept paper to begin the process of developing a new PtC document to be used in drafting a new guideline for IBC medications.

The concept paper addresses five problem statements put forth by EMA:

  • The criteria addressed in the 2003 PtC document utilizes recommendations set by a meeting known as Rome II. The standards have since been upgraded to Rome III, and EMA recommends the new PtC standard incorporate the updated criteria.
  • Upgraded standards must do a better job at defining whether patients suffer from "short term" symptoms-as do approximately 95% of those suffering from IBS-or from "long term" symptoms requiring constant, as opposed to periodic, treatment.
  • There is disagreement between regulatory authorities regarding the appropriate endpoints used to determine the success of an IBS treatment, and the disagreement warrants further discussion and clarification. EMA said it hopes to harmonize its guidelines with those of the US Food and Drug Administration's to the extent possible.
  • The existing PtC does not address the safety and efficacy needs for all IBS patients-an oversight that should be corrected in the new version of the PtC.
  • The development and testing of treatments for medicines intended to treat IBS is increasingly being conducted abroad. This represents unique challenges which the 2003 PtC document does not address.

EMA said it expects the draft guideline for IBS to be released during the fourth quarter of 2012, with revisions to come into effect by 2013.

Read more:

EMA - Concept paper on the revision of the CHMP points to consider on the evaluation of medicinal products for the treatment of irritable bowel syndrome

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