All Regulatory affairs articles
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Journal
Environmental impact of pharmaceuticals and regulation in the EU
The profound impact of pharmaceuticals on the environment has been acknowledged for decades. In the EU, two key mechanisms that assess this risk are the Environmental Risk Assessment (ERA), and Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). As both frameworks are under assessment, this article looks at the key considerations within the ERA.
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Case Study
Case study: The evolving regulatory environment
Reproduced from a webinar presentation, made in collaboration with TOPRA and Roche, given on December 15 by Caroline Kuhn, François Hebraud, and Vijay Reddi, of Roche.