EMA: Report on Nitrosamine Impurities
The European Medicines Agency (EMA) and the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) have jointly published a comprehensive report on nitrosamine impurities in human medicines, summarising key regulatory and scientific developments since their discovery in 2018.
Initially detected in certain blood pressure medicines (sartans), nitrosamine impurities have since raised significant safety and quality concerns across multiple drug classes. The newly released report outlines the European medicines regulatory network’s response to this issue and sets the course for future regulatory action.
Key Highlights from the Report:
- Scientific Reviews: The report reflects on milestone evaluations, including Article 31 reviews of sartans and ranitidine, and the Article 5(3) review of all human medicines under Regulation (EC) No 726/2004.
- Regulatory Framework: It describes the evolving regulatory strategies to detect, assess, and control nitrosamine impurities.
- Scientific Progress: Advances in the understanding of nitrosamines’ quality and safety profiles are presented.
- International Collaboration: EMA and CMDh emphasise their harmonised EU approach and ongoing cooperation with global partners, industry stakeholders, and healthcare professionals
Source:
EMA: Nitrosamine impurities in human medicines - Report
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