ICH M7: APIC's "How to do"- Document

In April 2023, the responsible task force of APIC, a sector group of CEFIC, 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. The "How to Do" document and associated template 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. In detail, the contents, recommendations and explanations of the document were discussed in our recent news item "APIC: ICH M7 "How to Do" Document Released".

All attendees of this year's APIC/CEFIC Global GMP & Regulatory API Conference, which will be held as a hybrid event in Berlin, Germany, October 25-26, 2023, will receive a copy 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." For more information on the full event agenda, please visit the 26th APIC/CEFIC Global GMP & Regulatory API Conference website.