EMEA, FDA to Increase Non-EU Site Inspections

The European Medicines Agency (EMEA) is planning to join the FDA in increasing the number of good clinical practice inspections at clinical trial sites outside North America and Western Europe. In a strategy paper posted to the EMEA website, the agency says approximately one-quarter of the patients in pivotal trials submitted to support European Economic Area marketing authorization applications between 2005–2008 came from Africa, Asia, Latin America, and Russia and other members of the Commonwealth of Independent States.
Clinical Trials Advisor