EU regulators should copy US FDA over combination product guidelines, says expert
In Europe, drugmakers hoping to get their combination delivery systems to market have to gain approval for the compound and device separately. However in the US there is an official process.
Speaking at this year’s Pharmapack Europe, Fournier said the EU process is a drain on time, money and resources for manufacturers, and urged EU authorities become more like the US FDA (Food and Drug Administration).
She said:“Regulation is really complex especially if you look at different regions in the world. First the definition of combination product is different in US and Europe.
“However the FDA recognises that compliance could be achieved by following one set of guidelines focussed on the performance of the two combined. if more became like the FDA it would be easier.”
Fournier added that if there was more harmony between the regulatory processes throughout the world it would ease combination products’ route to market.
