EMA joins reg­u­la­to­ry coali­tion in call­ing for RWE to be in­te­grat­ed in­to reg­u­la­to­ry de­ci­sions

As more and more biotechs are look­ing in­to the po­ten­tial ap­pli­ca­tions of us­ing re­al-world ev­i­dence in reg­u­la­to­ry sub­mis­sions, the Eu­ro­pean Med­i­cines Agency is call­ing for more wide­spread adop­tion.

EMA en­dorsed a state­ment pub­lished Fri­day by ICM­RA, the In­ter­na­tion­al Coali­tion of Med­i­cines Reg­u­la­to­ry Au­thor­i­ties, high­light­ing the use of both RWE and re­al-world da­ta in de­vel­op­ment and reg­u­la­to­ry au­tho­riza­tions, not­ing their role

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