- All > Quality and Safety: Medicines > Regulatory Support
- All > Quality and Safety: Medicines > Safety and Efficacy
- Keywords > drug safety
- Keywords > medicines regulatory authority (MRA) - announcements
- Keywords > medicines regulatory systems
- Keywords > national medicines regulatory - mechanisms
- Keywords > national regulatory authority (NRA)
- Keywords > national regulatory systems - assessment
- Keywords > national reporting systems - adverse reactions to medicines
- Keywords > pharmacovigilance reporting system
- Keywords > post marketing surveillance
- Keywords > safety alerts
(2011; 1 page)
Nwokike, Jude and Andy Stergachis. 2010. Actions of the National Regulatory Authorities in Developing Countries following US FDA and EMA Safety Alerts on Rosiglitazone. Strengthening Pharmaceutical Systems (SPS) Program. Arlington, VA: Management Sciences for Health.
On September 23, 2010, the US Food and Drug Administration (FDA) announced that it will require a restricted access program for the elevated cardiovascular risk associated with rosiglitazone. The same day, the European Medicines Agency (EMA) recommended marketing suspension for medicines containing rosiglitazone. Before these regulatory actions, safety concerns had sent global sales of Avandia® sliding dramatically from $2.2b in 2006 to $1.2b in 2009. We monitored the actions of national regulatory authorities (NRA) from developing countries in relation to rosiglitazone using a metric from the indicator-based pharmacovigilance assessment tool (IPAT) developed by the USAID-funded Strengthening Pharmaceutical Systems program. One of the core indicators of the IPAT is the average time lag from safety signal to communication.
Identify time lag between the announcements on rosiglitazone by stringent regulatory authorities (SRAs) as represented by FDA and EMA, and actions by national regulatory authorities (NRA) from selected developing countries.