APIC: ICH M7 "How to Do" Document published

The first version of the "Sharing Drug Substance M7 information to HA and MAH: "How to do" document -Interpretation of the ICH M7 guideline and other relevant guidelines with regard to M7 data sharing" and the associated templates were finalised in March and April 2023 and are now available on the APIC website. They can be seen as complementary and explanatory to the ICH Guideline "ASSESSMENT AND CONTROL OF DNA REACTIVE (MUTAGENIC) IMPURITIES IN PHARMACEUTICALS TO LIMIT POTENTIAL CARCINOGENIC RISK M7(R2)", which is now available in revision 2. 

The responsible task force of APIC, which is a sector group of the European Chemical Industry Council (CEFIC), wants to use the "How to do" document to provide recommendations and explanations for active substance manufacturers to facilitate data exchange with regulatory authorities and marketing authorisation holders with regard to mutagenic impurities and their consideration. Here, the recommendations for new submissions and notifications of changes as well as for fermentatively and semi-synthetically produced active substances are described and considered separately.

The "How to do" document is divided into the following eight chapters and sub-chapters:

1. Introduction
    BACKGROUND
    THE OBJECTIVE OF THE DOCUMENT
    SCOPE OF THE DOCUMENT
2. ICH M7 Guideline requirements regarding Information sharing
3. New submission (DMF/ASMF & CEP) - Sharing M7 information to HA
    Guideline requirements examples (ICH M7, EU, EDQM, Ph.Eur)
    What data to provide & where to include the data
4. New submission (DMF/ASMF, CEP) - Sharing M7 information to MAH
    Guideline requirements examples (EU, EDQM)
    What data to provide & where to include the data
    How to submit
5. Post-approval change (DMF/ASMF & CEP) - Sharing M7 information to HA
    Guideline requirements (ICH, EU, EDQM)
6. Post-approval change (DMF/ASMF, CEP) - Sharing M7 information to MAH
    Guideline requirements
    What data to provide & where to include the data
7. Data sharing for Fermentation Products - to HA & MAH
    Guideline requirements
    What data to provide & where to include the data
8. Data sharing for Semi-synthetic products
    Guideline requirements
    What data to provide & where to include the data

In addition, the "Appendix - Decision tree on Retrospective M7 Assessment (prepared in Step 1 of APIC M7 TF)" lists some possible scenarios and decision paths for the M7 assessment.

The first version of the "Sharing Drug Substance M7 information to HA and MAH: "How to do" document -Interpretation of the ICH M7 guideline and other relevant guidelines with regard to M7 data sharing" as well as the corresponding templates can be found on the APIC website in the Publications section.