ICH 协调指导原则【英文版】ICH_S1BR1_Step2_DraftGuideline_2021_0510.pdf

INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED GUIDELINE ADDENDUM TO THE GUIDELINE ON TESTING FOR CARCINOGENICITY OF PHARMACEUTICALS S1B(R1) Draft version Endorsed on 10 May 2021 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. S1B(R1) Document History Code History Date S1B(R1)* Endorsement by the Members of the ICH Assembly 10 May 2021 under Step 2 and release for public consultation. *This addendum is complementary to the S1 Guidelines (S1A, S1B and S1C(R2)) and is not intended to replace the existing S1B Guideline. At Step 4 of the ICH process, this addendum will be integrated with the S1B Guideline. Legal notice: This document is protected by copyright and may, with the exception of the ICH logo, be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided that ICHs copyright in the document is acknowledged at all times. In case of any adaption, modification or translation of the document, reasonable steps must be taken to clearly label, demarcate or otherwise identify that changes were made to or based on the original document. Any impression that the adaption, modifi