Integration of genomics in the regulatory decision-making process

By William Chin, PhD, Project Manager, EUCRAF

Tong W et al. from the National Center for Toxicological Research, US Food and Drug Administration published an article entitled “Genomics in the land of regulatory science” in the 18 March 2015 issue of the Regul Toxicol Pharmacol journal.

The role of genomics in personalized medicine is gaining importance in recent times. The focus of this article was to summarize the Global Summit on Regulatory Science (GSRS2014) held in August 21–22, 2014, hosted by the Global Coalition for Regulatory Science Research (GCRSR). The GCRSR was set up by the FDA in 2013 as an international collaboration of regulatory agencies that has a special interest promoting emerging technologies such as genomics in the regulatory decision-making process.

One of the key objective during this summit was to address how regulatory practices and approaches should be developed around new genomics technologies; and the best practices and guidelines for emerging genomics programs in regulation.

In addition to the logistical challenges in slow translation of basic science to regulatory application, technical challenges between genomics and regulatory science such as data sharing, analytical protocols and development of standardized protocols were highlighted.

It was recognized that there is a need for a global path in the establishment of a regulatory bioinformatics framework for the development of transparent processes in the management of food and medical product safety risks.

To address these issues, the importance of bioinformatics as an essential tool in the application of genomics technology in regulatory science was highly emphasized. Bioinformatics solutions are required to distil meaningful knowledge in times where genomics data is abundant and easily generated.

Training for both regulators and regulated industries as a principle means for advancing regulatory science was also highlighted an important step toward advancing the role of genomics in regulatory processes globally.


1. Regul Toxicol Pharmacol. 2015 Mar 18. pii: S0273-2300(15)00055-0. [Epub ahead of print]. Genomics in the land of regulatory science. Tong W, Ostroff S, Blais B, Silva P, Dubuc M, Healy M, Slikker W.