Ire­land added to EMA/FDA joint gener­ic in­spec­tion ini­tia­tive

An­oth­er Eu­ro­pean coun­try has been added to the ros­ter of an EMA and FDA ini­tia­tive that al­lows the agen­cies to con­duct joint in­spec­tions and share in­for­ma­tion.

The EMA an­nounced ear­li­er this week that Ire­land has been added to the ini­tia­tive, join­ing Aus­tria, France, Ger­many, Italy, the Nether­lands and Spain. The pro­gram it­self, which was an­nounced back in 2013, is de­signed to al­low both the EMA and the FDA to share in­for­ma­tion about in­spec­tions and for the agen­cies to joint­ly sup­port mar­ket­ing au­tho­riza­tion ap­pli­ca­tions for gener­ic med­i­cines.

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