EU Drug Approvals Could Be Denied If Environmental Risks Not Properly Assessed

EU Drug Approvals Could Be Denied If Environmental Risks Not Properly Assessed

May 24, 2023, Pharma Intelligence

The firm’s analysis of the effects EU environmental risk assessments (ERAs) would have on the pharmaceutical industry was included in an article appearing in The Pink Sheet.

According to a Covington blog post, the commission's proposals represent "a significant change to the existing regime" for environmental impact assessments.

For example, at present, if the ERA is incomplete at the time of the marketing authorization application (MAA), the authorities can ask the applicant to follow up with more information, "but the request is not enforceable," Covington's blog post noted.

"Currently, the only consequence for a medicine with clear environmental risks is a non-binding recommendation from the relevant competent authority that the medicine be sold with clear disposal instructions," it pointed out.

Furthermore, "holders of approvals granted before October 2005 - who did not originally need to submit an ERA - will have to evaluate their existing products and submit data on environmental risk," Covington pointed out. The European Medicines Agency "will prioritize its requests for assessment based on the risk posed by the particular product or active substance," it added.

The ERA would also have to "specify whether the product is classed as hazardous to human health or the environment under EU chemicals legislation, and propose risk mitigation measures to reduce discharges and emissions into the environment."