IPQ Final | Page 9

Monthly Update/ September 2023

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Monthly Update/Article

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environmental/green goals that Europe is puIncluded in this part of the story is the late April release by the European Commission of a proposal for revising pharmaceutical legislation, which has implications for environmental risk assessments and CMC/GMP expectations.

implementing constructive and viable environmental policies that do not carry with them unintended consequences counterproductive to the health enhancement goals.

PART I: European Regulatory Network Support for Manufacturing Innovation

The story begins with a call from EFPIA for input and support from the medicine regulatory network in Europe’s effort to achieve its environmental goals. The need for more effective communication across environmentally-related legislative efforts about their potential impact on medicines was a key theme at a session of the March 2023 DIA Europe conference.

At the session, EDQM shared its experience in working collaboratively with European and international regulatory stakeholders on N-nitrosamines in accord with the unfolding science and the need to preserve patient access to critical medicines.

Industry is Urging EMA to Increase its Focus on Medicine Impact of EU Food

News in depth

September 2023

https://drive.google.com/file/d/1nPh8-ckCxmNOTzEDoHDeiuFrcJ1zcR_G/preview

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