FDA’s Updated GLP Rules Will Disallow Most Academic Non-Clinical Studies from Regulatory Applications
[Posted on: Thursday, August 25, 2016]

This week FDA announced a major modernization of the GLP rules primarily aimed at adding detailed quality system requirements such as requiring that GLP facilities maintain detailed SOPs on the responsibilities of management, period assessment of the quality system, and electronic documentation. Per the new rules the management of a given facility will be held responsible for any deficiencies identified in the quality systems. The new GLP rules clarify that these rules apply to all animal studies, whether conducted to evaluate toxicity, efficacy, proof of concept, and studies needed for products approved via the Animal Efficacy Rule. The new rules state that management is responsible for establishing and maintaining conditions and procedures necessary for the conduct of nonclinical laboratory studies compliant with GLPs; the study director, as the sole point of study control, is responsible for implementing those procedures in specific studies; and the QAU is responsible for inspecting and general oversight of studies, verifying that they are GLP compliant or recommending changes needed for bringing them into compliance. The 142 page document gives excruciating details of the current GLP rules. For example, it requires that all samples and records be archived no later than 2 weeks after completion of the study, and the full report be written no later than 6 months after the study is completed. Most of these new rules were created based on the feedback obtained from the industry and represent standard practices at commercial GLP labs. However, most academic labs do not have the resources to implement such detailed quality systems thereby rendering any non-clinical studies conducted at such labs unacceptable in support of any regulatory application such as IND or NDA. Academic centers conduct significant number of non-clinical studies and publish them in peer-reviewed literature. Many of these studies form the rationale for further clinical development and may be submitted to the IND. Sponsors have been able to claim in the past that these studies were conducted in compliance with GLP provided they were able to general full study reports. Under the current rules for have defined management and QAU, that may be no longer possible. If you need to use your study in support of regulatory applications, you will need to get the studies done at commercial GLP centers.