In June 2024, the Assembly of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) decided to establish the ICH M7 Sub-group: Addendum to ICH M7 on Risk Assessment and Control of Nitrosamine Impurities (hereinafter referred to as the “M7 Sub-group”). Entrusted by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), China Pharmaceutical Innovation and Research Development Association (PhIRDA) successfully recommended two experts to the IFPMA ICH M7 Sub-group. The two experts will participate in drafting the Concept Paper and related Work Plan, as well as the implementation of the guideline. Below is the list of experts involved:

In January, the National Medical Products Administration (NMPA) of China released an announcement on the application of the ICH M7(R2) Guideline on the “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk”, aiming to further regulate the drug R&D and manufacturing processes, ensuring public medication safety. The IFPMA ICH M7 Sub-group will focus on developing the Addendum to the M7 Guideline, a harmonized set of acceptable intakes (AIs) standards, and relevant training materials and examples. It is expected to take three years for the sub-group to complete related work. Currently, China has adopted and implemented all the 69 ICH Guidelines. This demonstrates the country’s drug lifecycle regulation is rapidly aligning with international standards, which further attracts global innovative elements to China and provides robust support for Chinese innovative drugs to enter the international market.

As of August 2024, PhIRDA has successfully recommended 56 experts (including 11 Leads and 9 Alternates) to 29 IFPMA ICH Working Groups, accounting for 40% of the global experts of IFPMA.

Click to see PhIRDA IFPMA ICH Expert List.