The International Generic and Biosimilar Medicines Association (IGBA) commends the General Assembly of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) for its decision to develop  an Addendum to the ICH M7 Guideline on Assessment and Control of DNA Reactive (mutagenic) impurities, to incorporate the latest scientific advancements supporting the safety assessment and control of nitrosamine impurities into internationally harmonized guidance.

The International Generic and Biosimilar Medicines Association (IGBA) welcomes the decision of the ICH General Assembly to re-elect the IGBA as a Management Committee Member of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). IGBA joined the ICH as a full member of the General Assembly in June 2016 and was elected to the Management Committee in 2018. 

Non-communicable diseases (NCDs) are on the rise and impacting the lives of people around the world. IGBA is pleased to join IFPMA, DITTA, GSCF, WHL, and PATH in a formal statement at WHA on the need for multistakeholder solutions to build a healthier, more sustainable future for all.