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.

A lake in the shape of the world's continents in the middle of untouched nature. A metaphor for ecological travel, conservation — Efforts are under way to reduce the environmental impact of pharmaceuticals • Source: Shutterstock

Pharmaceutical companies in the EU could face much stricter requirements in terms of environmental risk assessments (ERAs) of their medicines, including having their marketing authorization applications rejected if their ERAs do not pass muster, under proposals from the European Commission.

Regulators could also impose post-marketing conditions of use relating to environmental considerations, such as prescription-only status, while companies with marketing...