EMA and FDA will now share trade se­crets, al­low­ing both reg­u­la­tors to act on each oth­er's in­spec­tion re­ports

As part of a land­mark agree­ment forged in March, the FDA and Eu­ro­pean Med­i­cines Agency said Wednes­day that they will soon share non-pub­lic and com­mer­cial­ly con­fi­den­tial in­for­ma­tion, in­clud­ing trade se­cret in­for­ma­tion.

The an­nounce­ment is part of the im­ple­men­ta­tion of an agree­ment be­tween FDA and EMA to mu­tu­al­ly rec­og­nize one an­oth­er’s phar­ma­ceu­ti­cal man­u­fac­tur­ing in­spec­tions, which will like­ly re­duce du­plica­tive in­spec­tions and low­er costs for both reg­u­la­tors.

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