Drugs

FDA, Regulatory Partners Agree on Alternative Endotoxin Test

FDA and the International Coalition of Medicines Regulatory Authorities (ICMRA) have completed an assessment of a new biologics testing approach that could reduce use of horseshoe crab blood while continuing to ensure product quality.

The assessment is part of the ICMRA Collaborative Assessment Pilot, which brings participating international regulators together to review proposed manufacturing changes at the same time, coordinate their questions to applicants, and make their own independent decisions within a standard 120-day review timeline, an FDA notice says. The pilot was established to improve consistency in regulatory expectations, reduce duplicative submissions and assessments, and facilitate more timely patient access to medicines.

“Endotoxins are harmful substances released by certain bacteria that can cause serious adverse reactions in patients; testing for their presence is a critical safety and quality step in manufacturing biological products,” FDA explains. “The collaborative assessment evaluated the use of a recombinant endotoxins test as an alternative to the traditional Limulus Amebocyte Lysate (LAL) test, which relies on blood from horseshoe crabs. The submission, structured as a Post-Approval Change Management Protocol (PACMP), covered several biological products across multiple therapy areas, including cancer, cardiovascular, respiratory, and rare diseases.”

FDA notes that recombinant endotoxin testing does not require horseshoe crab-derived materials and supports the agency’s commitment to modernizing pharmaceutical testing and reducing reliance on animal-derived materials.

FDA participated in this assessment with international partners - Australia’s Therapeutic Goods Administration, Health Canada, Japan’s Pharmaceuticals and Medical Devices Agency, and Swissmedic, with the European Medicines Agency serving as the leading authority for this submission under the pilot.

FDA will continue working with international partners to support modern testing methods and approaches that advance pharmaceutical quality while protecting public health. Work is underway to build on the pilot and develop a more sustainable, globally coordinated regulatory approach.

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