Print

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.

Read More

Share this page!

Contact Info

IGBA | INTERNATIONAL GENERIC AND BIOSIMILAR MEDICINES ASSOCIATION

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

E-mail: 
This email address is being protected from spambots. You need JavaScript enabled to view it.  

Follow us on: Twitter - LinkedIn - YouTube

We use cookies to improve our website and your experience when using it. Cookies used for the essential operation of the site have already been set. To find out more about the cookies we use and how to delete them, see our Privacy Policy.

I accept cookies from this site