Inspections of clinical trial sites in third countries pose difficulties for regulators. Need to research local requirements, translation issues, travel, both to and within a country, and other factors increase the time and resources required to conduct inspections in third countries.
Recent data shows more than 60 per cent of sites in marketing authorisation applications (MAA) submitted to the European Medicines Agency (EMA) were located outside of Europe. Below (attachment) is a map of all good clinical practice (GCP) inspections conducted by the EMA from 2000 to 2009.
EMA-GCP.pdf (484.9 KB)