EMA opens con­sul­ta­tion on guide­line for ad­vanced ther­a­pies in clin­i­cal tri­als

The EMA on Thurs­day opened for con­sul­ta­tion a new guide­line on the struc­ture and da­ta re­quire­ments for a clin­i­cal tri­al ap­pli­ca­tion for ex­plorato­ry and con­fir­ma­to­ry tri­als with ad­vanced ther­a­py in­ves­ti­ga­tion­al med­i­c­i­nal prod­ucts (ATIMPs).

The 53-page guide­line ad­dress­es de­vel­op­ment, man­u­fac­tur­ing and qual­i­ty con­trol, fea­tur­ing sec­tions on qual­i­ty doc­u­men­ta­tion (in­clud­ing parts on the ac­tive sub­stance and the in­ves­ti­ga­tion­al med­i­c­i­nal prod­uct), non-clin­i­cal doc­u­men­ta­tion and clin­i­cal doc­u­men­ta­tion.

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