EU pharmacovigilance legislation implementation likely to be staggered
This article was originally published in SRA
Executive Summary
The European Medicines Agency is unlikely to meet all its requirements under the far reaching pharmacovigilance legislation by the original implementation deadline of July 2012. Instead, the agency will implement the legislation in phases, beyond the deadline, Peter Arlett, head of pharmacovigilance and risk management at the EMA, has said.
You may also be interested in...
Constitutional Complaints In Germany Cast Doubt Over Fate Of UPC
The UK’s withdrawal from the EU could upset the Unitary Patent Court project.
Will COVID-19 Drive The Decline Of International Reference Pricing?
International reference pricing has created narrow price corridors that can limit access to medicines and vaccines in lower income countries. The issue will start to impact higher income EU markets if US plans to introduce IRP come to fruition.
EU Orphan And Pediatric Proposals Insufficient, Says Industry
Innovators warn against slashing incentives and argue a lack of a common definition of unmet need is a stumbling block to proposals.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: