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Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories.  It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).

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M1 MedDRA Terminology
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M2 Electronic Standards
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M3 Nonclinical Safety Studies
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M4 Common Technical Document
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CTD: The Common Technical Document
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The Common Technical Document was agreed upon by the Steering Committee in November 2000. Due to the development of this topic over the years, all information about the CTD are available on the CTD page under the Work Products.

CTD page

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M5 Data Elements and Standards for Drug Dictionaries
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M6 Gene Therapy
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M7 Mutagenic Impurities
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M8 Electronic Common Technical Document (eCTD)
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M9 Biopharmaceutics Classification System-based Biowaivers
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M10 Bioanalytical Method Validation and Study Sample Analysis
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M11 Clinical electronic Structured Harmonised Protocol (CeSHarP)
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M12 Drug Interaction Studies
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M13 Bioequivalence for Immediate-Release Solid Oral Dosage Forms
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M14 Use of real-world data for safety assessment of medicines
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M15 General Principles for Model-Informed Drug Development
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