FDA, we work closely with national regulatory agencies around the world
on issues relating to the safety, efficacy and availability of medical
products. An exciting example of such collaborative efforts is the
Common Electronic Submissions Gateway (or CESG), an outcome of the US-Canada Regulatory Cooperation Council (RCC). Through
a cooperative research and development agreement, FDA worked with our
counterparts in Health Canada, to share technology that will make it
more efficient for industry to submit applications to both the U.S. and
Canada for the approval of pharmaceutical and biological products. A
common infrastructure would enable industry to submit to both countries
using the same electronic format for technical documents.
RCC Initiative was announced in February 2011 by President Barack Obama
and Prime Minister Stephen Harper. Its goals are to promote economic
growth, job creation and benefits to consumers and businesses through
increased regulatory transparency and coordination. The electronic
submissions gateway is one such project designed to meet those goals.