Regulatory Focus™ > News Articles > US, EU Officials in Tangle Over Mutual Reliance on Drug Facility Inspections: Report

US, EU Officials in Tangle Over Mutual Reliance on Drug Facility Inspections: Report

Posted 20 May 2014 | By Alexander Gaffney, RAC 

US, EU Officials in Tangle Over Mutual Reliance on Drug Facility Inspections: Report

US and EU trade negotiators are reportedly hung-up over how—or if—to rely on the results of one another's regulatory inspections of drug manufacturing facilities, threatening to derail part of the Trans-Atlantic Trade and Investment Partnership (TTIP), The Wall Street Journal reports.

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 Journal piece 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.

Read the Journal story here.


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