The Mutual Recognition Agreement Rolls Along – But Where is Germany?

By Mark I. Schwartz — Earlier this month the FDA recognized the drug inspectorates of Ireland and Lithuania for purposes of the Mutual Recognition Agreement (MRA), and in March of this year, the agency recognized the drug inspectorates of Greece, Hungary, the Czech Republic and Romania. Indeed, it was last October 2017, that FDA made its long anticipated announcement recognizing the first European drug regulatory authorities capable of conducting inspections of manufacturing facilities that meet FDA requirements, namely, those in Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the UK. We have previously blogged about the MRA here, here, and here. But where, oh where, is Germany? No offense to such national pharmaceutical behemoths as Malta, Croatia and Lithuania, but Germany is the fourth largest pharmaceutical market in the world and is, by far, the largest in Europe.  It is also home to dozens of pharmaceutical and biologics manufacturing facilities, and…

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