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Regulatory Focus™ > News Articles > FDA Proposes New Rule to Overhaul Regulations for Nonclinical Studies

FDA Proposes New Rule to Overhaul Regulations for Nonclinical Studies

Posted 23 August 2016 | By Zachary Brennan 

FDA Proposes New Rule to Overhaul Regulations for Nonclinical Studies

The US Food and Drug Administration (FDA) on Tuesday proposed to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach for these safety and toxicity studies.

The 142-page proposed rule outlines what’s referred to as a “GLP Quality System,” which will involve additional management responsibilities and standard operating procedures (SOPs), as well as a more nuanced approach for multi-site studies.

“These proposals are intended to build quality into planning, conducting, and reporting a nonclinical laboratory study and to help ensure data quality and integrity,” FDA says.

The proposed rule, which follows the publishing of an advanced notice of proposed rulemaking (ANPRM) in December 2010, would also further expand the scope of the regulations to include all products for which nonclinical laboratory studies are currently conducted that are not explicitly discussed in the current regulations, specifically tobacco products.

In addition, the proposal would introduce and modify definitions, terms, and organizational and personnel roles and responsibilities – for everything from attending veterinarian to raw data to adding a definition for “Lead Quality Assurance Unit [QAU].” The proposed rule would also help to harmonize FDA with international regulations by incorporating wording consistent with domestic and international guidelines covering GLP, such as those established by the Organization for Economic Cooperation and Development.

Furthermore, the proposed revisions seek to require sponsors to take note when a study is stopped. Under the proposal, a study’s director would need to write, sign, and date a short written summary report closing the study and discussing why a study was discontinued.

In terms of how much this proposed rule might cost industry when finalized, FDA estimates that annual costs would include the additional reporting and recordkeeping responsibilities required under the GLP Quality System, while one-time costs include reading and understanding the rule, updating existing SOPs, writing new SOPs and training.

“Combined, all costs annualized over a ten-year period at a 7-percent discount rate are estimated to range between $34.4 million and $69.3 million, with an average annualized cost of $51.9 million. By contrast, with a 3 percent discount rate, annualized cost would range from $34.2 million to $68.9 million, with an average annualized cost of $51.5 million,” FDA says.

GLP Quality System

Under the proposed GLP Quality System, FDA says it expects such a system will provide the appropriate framework for building quality into nonclinical laboratory studies and will result in more reliable data for FDA to consider when making regulatory decisions.

Implementation of such a system is also expected to provide for a more flexible framework to help ensure quality in planning, conducting and reporting nonclinical laboratory studies.

The modernization of the GLP regulations is also an attempt to further the agency’s efforts to encourage the implementation of the principles of the “3Rs”: to reduce, refine and replace animal use in testing.

“We agree with the numerous comments to the December 2010 ANPRM that support a clear delineation of study responsibilities and effective communication among all parties involved in multisite studies,” FDA adds, noting that some stakeholders suggest that certain provisions in the current regulations are outdated and hamper efficient use of present technology (ie., requiring hard copies of records and documentation instead of allowing computerized options).


Because the number of FDA inspections at nonclinical sites is limited by competing priorities and limited resources, FDA says it looks to sponsors and nonclinical lab management staff to ensure that data submitted to FDA in support of applications and submissions are reliable, particularly for those nonclinical studies that form the basis for allowing a new medical product into first-in-human clinical studies.

Along those lines, FDA has proposed introducing the term “facility-based inspection” to mean a QAU inspection that covers the general facilities and activities; for example, installations, support systems, computer systems, training, environmental monitoring, and equipment maintenance and calibration.

Meanwhile, FDA also proposes adding a definition for “process-based inspection,” and in order to ensure that any problem revealed during such an inspection is properly captured in the reports of all relevant studies, FDA proposes adding a requirement for a preparation of a written certification by the person conducting a phase of the study.

Comments on the proposed rule can be submitted to FDA over the next 90 days.

Proposed Rule: Good Laboratory Practice for Nonclinical Laboratory Studies


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