At issue, the Journal‘s Matthew Dalton writes, is that while the US Food and Drug Administration (FDA) is willing to cooperate closely with the European Medicines Agency (EMA) on drug inspections—something it already does extensively—it’s less willing to accept inspectional findings from some individual EU nations, and in particular those in Eastern Europe. At their best, routine inspections of manufacturing facilities ensure that good manufacturing practices are being followed, staff are well trained, documents are being properly maintained, materials meet quality standards, ingredients are properly stored and accounted for and the end product is not contaminated. But at its worst, an inspection that is not properly conducted could gloss over—or even ignore—problems, potentially subjecting patients to serious problems.
And as the Journalpiece notes, US regulators aren’t convinced the Eastern EU member states, such as Romania and Bulgaria, are up to the challenge of regulating manufacturing facilities. Those countries have only recently joined the EU, and have far less regulatory experience than do their wealthier Western European counterparts.
REFERENCE: Regulatory Focus; Alexander Gaffney, RAC; 20 MAY 2014