FDA of­fers a pro­pos­al to help gener­ic drug de­vel­op­ers get si­mul­ta­ne­ous ap­provals in mul­ti­ple mar­kets

The FDA re­vealed Thurs­day that it’s of­fer­ing a pro­pos­al to the In­ter­na­tion­al Coun­cil on Har­mon­i­sa­tion — ICH — to bet­ter har­mo­nize sci­en­tif­ic and tech­ni­cal stan­dards for gener­ic drugs.

The plan is to let gener­ic drug de­vel­op­ers im­ple­ment a sin­gle glob­al drug de­vel­op­ment pro­gram, with com­mon el­e­ments of ap­pli­ca­tions to file, which will al­low for si­mul­ta­ne­ous ap­provals in mul­ti­ple mar­kets.

“This would make it eas­i­er for de­vel­op­ers that would oth­er­wise on­ly seek gener­ic drug ap­proval in one re­gion to al­so seek ap­proval in the Unit­ed States, in­creas­ing com­pe­ti­tion in Amer­i­ca. And it would al­so make it eas­i­er for de­vel­op­ers that would oth­er­wise on­ly seek gener­ic drug ap­proval in the US mar­ket to gain ac­cess to oth­er mar­kets,” FDA com­mis­sion­er Scott Got­tlieb said in a state­ment.

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