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European Pharmacovigilance Update Still Causing Concern

 
• By Faraz Kermani

The European pharma industry understands the need to tighten EU pharmacovigilance rules, but increased powers for a new advisory and assessment body could signal trouble ahead.

The European Commission is going to great lengths to guide companies in the right direction toward living with the new pharmacovigilance legislation that comes into force in July.

Its publication of transitional arrangements for the new regime on Feb. 21, and the European Medicines Agency’s subsequent release for public consultation of good pharmacovigilance practice modules a day later, have gone some way toward calming industry nerves

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