As the FDA now communicates with its European counterparts on a daily basis, the US agency has decided to make the move from London to Amsterdam alongside the EMA.
“By maintaining an office in both Brussels and London (eventually Amsterdam), we can better leverage our resources and collaborate with our regulatory partners on higher-risk sites around the globe that sell food and medical products to both Europe and the United States,” the FDA’s Anna Abram and Mark Abdoo wrote in a blog post Thursday.
According to the EMA’s timeline for tracking their relocation, the permanent building in Amsterdam will be fully operational by 15 November 2019 and staffers will relocate by 31 December 2019.
The FDA’s presence in foreign countries has expanded since opening its first office in Beijing in November 2008. Additional foreign offices are in New Delhi (to better track active pharmaceutical ingredients (API), raw materials, finished drugs and various food products including spices); Brussels (the headquarters of the EU); and London — soon to be Amsterdam (the headquarters of EMA), among others.
As of 14 August, the FDA told Focus that the FDA’s India office has 14 US direct hires on staff (of which six are currently deployed to India while others await deployment) and five locally employed staff. But not all India-based office employees are investigators, and India office staff who perform inspections share the inspectional burden with FDA investigators based in the US who travel to India on temporary assignments.
The FDA’s China office as of 14 August had 20 US direct hires on staff, with six waiting deployment and six locally employed staff. That compares with a previous tally from December 2015 of 17 employees assigned to its Beijing office. But as with India, not all China Office employees are investigators, and China staff that perform inspections share the inspectional burden with US-based investigators deployed on temporary assignments, the FDA said.
“Today, our approach to information-gathering and sharing has become an important function of our foreign offices. They feed information into Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT), a risk-based tool developed by FDA to screen all regulated shipments imported or offered for import into the United States. Our foreign offices also use Global Watch for communicating with FDA Centers and our Office of Regulatory Affairs about emerging trends relevant to the agency’s public health mission,” Abram and Abdoo write.
First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email firstname.lastname@example.org for more information.
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