Submission requirement for translation



  • Hi. The company medical/regulatory staff needs to review the material prior to submission to PAAB. When the material was already approved in English (internally and by PAAB), is it mandatory for medical/regulatory staff to review the translation too? The translations are done and reviewed by certified translators.
    Thank you



  • Hi @Sil

    No, it is not required that medical/regulatory staff review the translation. As a reminder, Code s.1.4G states “The sponsoring company shall be responsible for accuracy of translation of APS".


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