EFPIA Statement on the Extension of Activities Concerning EU/US Site Inspections

EFPIA welcomes the next phase of the Mutual Recognition Agreement between the EU and US and their respective authorities – the European Medicines Agency and the Food and Drug Administration – on the inspection of sites to ensure adherence to Good Manufacturing Practice. Started on 1 November 2017, the extension of operations is aimed at recognising inspections of manufacturing sites for human medicines conducted in the respective territories. 

EFPIA has maintained consistently that uniformity in the reporting of inspection findings by the EU and US will be of significant value to global health authorities, industry, and the general public. On this basis, informed comparisons can be made of the relative compliance statuses of different facilities or the same facility at different points in time, enabling in turn better informed, risk-based decision-making on the basis of unambiguous and transparent inspection results.

A clearer understanding of inspection results and the compliance status of a facility will mean that health authorities are able dedicate limited inspectional resources to those facilities that need the greater regulatory oversight.