New clin­i­cal tri­al sys­tem to soon be­come manda­to­ry in Eu­rope

The Eu­ro­pean Med­i­cines Agency sought to re­mind in­dus­try to­day that use of the new Clin­i­cal Tri­als In­for­ma­tion Sys­tem (CTIS) will be manda­to­ry for all new ap­pli­ca­tions as of Tues­day, Jan. 31.

Fol­low­ing a one-year, op­tion­al tran­si­tion pe­ri­od where spon­sors could still sub­mit un­der the Clin­i­cal Tri­als Di­rec­tive, the CTIS will soon serve as the sin­gle en­try point for sub­mis­sions and for reg­u­la­to­ry as­sess­ments, and all fil­ings will have to come un­der the Clin­i­cal Tri­als Reg­u­la­tion, EMA said.

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