Reactions 1152 - 19 May 2007

US FDA, EMEA look to harmonisepostmarketing surveillance

The US FDA, the European Medicines Agency (EMEA)and the European Commission have agreed a newimplementation plan for their confidential informationsharing agreement.* The focus of the new plan is onstreamlining pharmacovigilance requirements betweenthe parties, according to The Pink Sheet.

The regulatory agencies concur that postmarketingsurveillance activities need to be harmonised as much aspossible to minimise the burden on sponsors.Nevertheless, differences in both legislation and clinicalindications and practices will continue to be a hurdle todeveloping a global pharmacovigilance strategy. EMEAHead of Post-Authorisation Evaluation of Medicines forHuman Use, Mr Noel Wathion believes discussions willfocus on risk management rather than risk minimisationas the FDA and the EU operate within different legalframeworks. There are already difficulties in the EUhindering a harmonised approach on risk minimisationwithin the region, "let alone with other regions," headded.* see Reactions 969 p2; 800969095

FDA, EMEA to improve collaboration on risk management. FDC Reports - PinkSheet - Prescription Pharmaceuticals and Biotechnology 69: 33, No. 18, 30 Apr2007 801075008

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Reactions 19 May 2007 No. 11520114-9954/10/1152-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved