The Egyptian Drug Authority (EDA) announces a Public Consultation regarding the Guidelines for Nitrosamine Impurities in Drug Substances and Pharmaceutical Drug Products
Comments to be submitted through public consultation (Public Consultation Form) via the following email: dc.tech@edaegypt.gov.eg. The submissions should be in Soft Word Form.
To review the draft regulatory guideline, please click on the link https://edaegypt.gov.eg/media/f0peqyql/guidelines-nitrosamine-draft_1.pdf
Click to view the list https://edaegypt.gov.eg/media/z2vnv5k1/high-risk-apis-list-that-can-form-nitrosamine-impurities-3.pdf
