EU Drug Approvals Could Be Denied If Environmental Risks Not Properly Assessed
As part of its revision of the EU medicines legislation, the European Commission is proposing tighter rules to reduce the environmental impact of medicines. Companies may want to start thinking now about whether their current environmental risk assessment processes would meet the likely new requirements.
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Reforms to better enforce environmental risk assessments are intended to ensure timely delivery of data, and should not thwart marketing authorization applications, according to a European Commission representative.
EU Partnership Offers Funding For Projects On Inclusive Clinical Trials, Synthetic Data & Theranostics
Europe’s public-private partnership, the Innovative Health Initiative, is seeking research projects in areas including innovative trial designs and methodologies to speed up the development of treatments for rare and ultra-rare conditions, reducing the environmental impact of health care products, and cutting the use of animals in drug safety testing.
The controversial nature of some of the plans in the EU medicines legislative overhaul suggests a long road ahead for negotiations at the European Parliament and Council, with some “substantial amendments” likely along the way.