List of changes to the M7 Guideline and Addendum in line with the ICH process for the maintenance of the M7 Guideline:
The M7 document was physically separated into a main Guideline and a separate Addendum including the monographs;
In the main M7 Guideline, the HIV duration was changed from “>1-10 years to >10 years” to 6 “lifetime“;
In the main M7 Guideline, the monograph table was edited to include the 7 new monographs and 1 note;
In the Addendum, 7 new monographs and 1 note were added (see pages 4-51 of this document): Acetaldehyde, Dibromoethane, Epichlorohydrin, Ethyl Bromide, Formaldehyde, 12 Styrene, Vinyl Acetate;
In the main M7 Guideline and Addendum, standard grammatical and formatting edits were made;
In the main M7 Guideline and Addendum, additional corrections in content were made that were determined to be minor by the M7(R2) Maintenance Expert Working Group.
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