On August 24, 2016, the US Food and Drug Administration (FDA) issued a Proposed Rule on Good Laboratory Practice for Nonclinical Laboratory Studies (Proposed Rule), which broadens the application and authority of Good Laboratory Practice (GLP) regulations. The Proposed Rule imposes heightened quality requirements for laboratory studies, including safety and toxicity studies, that are intended to support both product applications and other regulatory submissions that are not directly related to product approval. The Proposed Rule also modifies provisions for the care and handling of animals under the so-called Animal Rule and expands requirements to encompass tobacco products. Interested parties have until November 22, 2016, to submit comments, suggestions and feedback.

The Proposed Rule requires the use of a complete quality system approach (GLP Quality System) for nonclinical laboratory studies when such studies support or are intended to support marketing applications or other submissions to FDA. FDA proposes to mandate use of a GLP Quality System that is consistent with International Organization for Standardization (ISO) standard ISO 9001:1994, “Quality Systems—Model for Quality Assurance in Design, Development, Production, Installation and Servicing”; “FDA’s Quality System Regulation (QSR)” in 21 CFR Part 820; and wherever possible, Organisation for Economic Co-operation and Development guidance documents for GLP.