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Regulatory Focus™ > News Articles > EMA Looks to Revise Guideline on Investigation Drug Interactions

EMA Looks to Revise Guideline on Investigation Drug Interactions

Posted 10 April 2017 | By Michael Mezher 

EMA Looks to Revise Guideline on Investigation Drug Interactions

The European Medicines Agency (EMA) has proposed to change the agency's guideline for investigating drug interactions.

The guideline, last updated in 2012, details how drugmakers should conduct interaction studies to evaluate the potential for drug-drug and drug-food interactions.

"Drug-drug interactions are a common problem during drug treatment and give rise to a large number of hospital admissions as a result of medically important, sometimes serious or even fatal adverse events," EMA writes in its current guideline.

The agency also says that studying drug interactions is growing more important as the European population ages, with more patients taking multiple drugs simultaneously.

According to the concept paper, the guideline needs to be updated to add additional study design recommendations and considerations, as well as clarifications on a handful of issues covered by the previous revision related to in vitro and in vivo studies and labelling.

As such, EMA is asking stakeholders, including drugmakers, academia, healthcare professionals and other regulators, to provide input on the concept paper during a three-month public consultation.

Following the public consultation, EMA says it will begin working on draft revisions, taking into account the comments received.


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