EU pharmacovigilance legislation: Industry scrambles to meet the new rules
In an era where adverse drug reactions (ADRs) account for 5% of all hospital admissions and public confidence in the pharmaceutical sector is at an all-time low, medicines safety is at the top of Europe's legislatice agenda. A direct outcome of this is the new pharmacovigilance legislation (Regulation (EU) No 1235/2012 and Directive 2010/84/EU), which comes into effect this July.
Reactions have been mixed with regard to the potential impact on drug development costs. "There are many opportunities for additional mandatory data requests by regulators after approval", stated EuropaBio Healthcare biotechnology director Miriam Gargesi. "However", she added, "it is difficult to estimate the exact impact". You can read the full MedNous article here.