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European Medicines Agency Publishes Draft Revised Guideline for Environmental Risk Assessment of Human Drugs

The European Medicines Agency (EMA) recently published a draft revision of its 2006 guideline on the environmental risk assessment (ERA) of medicinal products for human use. The draft guideline builds on two "questions and answers" documents related to the 2006 guideline that EMA published in 2011 and 2016 and a 2016 EMA concept paper on the revision of the 2006 guideline. The revised guideline also incorporates relevant methods and guidance that have come into effect since 2006, such as REACH, the Water Framework Directive, as well as newer Organisation for Economic Co-operation and Development (OECD) guidance documents and guidelines. Stakeholders are invited to send their comments to EMA by 30 June 2019.

Medications may enter the environment during their manufacture, use, and disposal. Market authorization for a new drug in the EU generally requires an ERA, although some drugs are exempted (e.g., renewals, some excipients). The ERA focuses on potential environmental releases associated with the indicated use of the product and relies on physico-chemical, environmental toxicological and fate information.

The revised guideline is much more detailed and introduces decision trees for guiding the phased ERA and identifying test requirements. Notable changes are  the addition of specific guidance on the testing of antibiotics and endocrine-active substances and guidance for the evaluation of food chain risks for potentially bioaccumulative drugs. In addition, the draft guideline proposes to limit the use of the aerobic transformation in aquatic sediment system test (OECD 308), a resource-intensive test that runs for over 100 days and generally requires labeled compound. While quantitative structure-activity relationships (QSAR) and read-across approaches cannot replace experimental study data, applicants are encouraged to minimize testing by relying on previously conducted studies by other marketing authorization holders or by relying on information available in the public domain.

For more than 20 years, Gradient scientists have assisted the pharmaceutical industry with their broad experience related to the environmental and mammalian toxicology of pharmaceutical compounds. We have conducted dozens of regulatory ERAs to support market authorization in the EU and the US for a wide range of active pharmaceutical ingredients, including complex assessments for hormonally-active and anti-infective drugs. We work closely with contract laboratories to design and oversee required testing and prepare the environmental assessment reports.

For more information regarding our pharmaceutical environmental assessment expertise or to understand how the revised EMA guidance might impact your products, please contact Tim Verslycke.