INTERNATIONAL COUNCIL FOR HARMONI SATION OF TECHNICAL
REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE
ICH HARMONI SED GUIDELINE
P EDIATRIC E XTRAPOLATION
E11 A
Draft version
Endorsed on 4 April 2022
Currently under public consultation
At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the
appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the
regulatory authorities of the ICH regions for internal and external consultation,
according to national or regional procedures.
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