HowtoPlanforandImplementMedDRA.pptVIP

Update from the MSSO MedDRA SubscriptionsPercent by Region MedDRA SubscriptionsPercent by Category MedDRA Subscriptions by Level Global Regulatory Timelines Regulatory Update Japan – required use of MedDRA for electronic filing start 1 October 2003 EU – Currently required for electronic filing of ADRs, January 2003 all ADR reporting. Starting 2003 all severe single case safety reports going back to 1995 must be electronically submitted before the start of 2004. USA – Rule completing government review. Sample of Current Regulators MedDRA MedDRA MSSO Current and Future Activities Translat