Pharma Already Bristling at Parts of EU Drug Overhaul

As the EU preps for a massive pharma regulation overhaul, industry groups have already begun leveling complaints. The reforms include simplifying the approval process, cutting approval timelines, and reducing exclusivity periods from 10 years to 8 years for new drugs, the key sticking point for pharma companies.

According to Zoey Becker, “Companies could extend their period of regulatory exclusivity if they launch their product in all EU member states, address diseases with unmet need, conduct comparative trials or launch drugs that treat multiple diseases.”

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(Source: Fierce Pharma, May 1^st, 2023)