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IGBA Welcomes update to ICH M7 on Assessment and Control of Nitrosamine Impurities (June 2024)

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.

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IGBA Re-Elected to ICH Management Committee (June 2024)

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. 

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Contact Info

IGBA | INTERNATIONAL GENERIC AND BIOSIMILAR MEDICINES ASSOCIATION

C/O DYN SA
Rue de Cornavin 11
1201 Geneva, Switzerland

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