Transcription of ICH HARMONISED GUIDELINE
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ICH HARMONISED GUIDELINE
INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE (ICH) ICH HARMONISED GUIDELINE APPLICATION OF THE PRINCIPLES OF THE ICH M7 GUIDELINE TO CALCULATION OF COMPOUND-SPECIFIC ACCEPTABLE INTAKES Addendum to M7(R2) Draft version Endorsed on 6 October 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. Note: This document contains only the list of the revisions to the M7(R1) GUIDELINE as well as the new monographs for the 7 new compounds Acetaldehyde, Dibromoethane, Epichlorohydrin, Ethyl Bromide, Formaldehyde, Styrene, and Vinyl Acetate, which are submitted for public consultation. Further to reaching Step 4, these revisions would be integrated into a complete M7(R2) GUIDELINE and Addendum documents.
1 List of changes to the M7 Guideline and Addendum in line with the ICH process for the maintenance of the M7 Guideline:2 3 1. The M7 document was physically separated into a main Guideline and a separate Addendum including the monographs;4 5 2. In the main M7 Guideline, the HIV duration was changed from “>1-10 years to >10 years” to
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