Fewer than one per cent of trial sites included in marketing authorisation applications (MAA) were inspected by the European Medicines Agency (EMA) from 2000 to 2009. This is, at least in part, because of lack of resources and the EMA explained how it works around these limitations.
“The key to the process is therefore to test, by sampling, the processes and systems for different regions/regulatory frameworks, companies, therapeutic areas, population types, orphan product, commercial or academic sponsor etc rather than validating sites per se”, writes the EMA.
Collaborations are also used to make better use of resources. These include working with the US Food and Drug Administration (FDA), which faces similar issues relating to inspection resources, and regulators in other countries.
By working with regulators in third countries the EMA aims to support and strengthen local supervision through capacity building, networking and information exchange. Taking these steps will help ensure sites in the supported country comply with good clinical practices (GCP).
Visualising report data
The EMA explained its collaboration and sampling strategies in a report looking at MAA it received from 2000 to 2009. Using information from the report Outsourcing-Pharma created the interactive map below. Data used in the visualisation is available here.
Displayed on the map are GCP inspections of a country’s trial sites as a percentage of its sites included in MAA submissions. For example, in MAA submitted in 2009 included data from 10 sites in Ireland and the EMA visited the country twice, so it is given a value of 20 per cent.
The map can be filtered to show the percentage of inspections in any year from 2005 to 2009. Furthermore, clicking on a region in the graph below filters the map to show data from countries in that part of the world.
Larger circles represent a higher percentage of inspected sites. A scale is presented below the map.