The two regulatory agencies are calling this the “first use of a framework allowing submission of a single application.” What exactly do they mean? They’ve allowed drugmakers to submit results of seven new tests that evaluate kidney damage during animal studies of new drugs.

The tests measure the levels of seven key proteins, or biomarkers, found in urine that can provide additional info about drug-induced damage to kidney cells, also known as renal toxicity, according to an FDA statement. In addition to those tests, the FDA and EMEA will now consider results from the seven new tests as part of their review processes. Although a decision by a drugmaker to collect info using the new tests is voluntary, if collected, it must be submitted to FDA.

“The development of these and other biomarkers can result in important tools for better understanding the safety profile of new drugs,” Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, says in the statement. “We hope these biomarkers will lead to human tests that detect drug-induced kidney injury in people earlier than is now possible, and help health care professionals better manage potential kidney damage from drugs.”

The statement goes on to say such tests could one day open the door to the approval of more powerful drugs, especially for diseases where renal toxicity currently prevents promising experimental drugs from being approved. With more sensitive tests for renal toxicity, the FDA believes it could approve such drugs because health care professionals could closely monitor patients and halt the use of a drug if early signs of renal toxicity appear.

Development of the new biomarkers was led by the Predictive Safety Testing Consortium, whose members include scientists from 16 drugmakers, according to the FDA. The PSTC was organized and led by the Critical Path Institute, a nonprofit that supports FDA research collaborations to improve the development of new meds.

Researchers from Merck and Novartis identified the new biomarkers, tested for accuracy and usefulness, and shared the findings with the consortium, which submitted applications for use of the biomarkers to FDA and EMEA.