FDA to fol­low EMA with move from Lon­don to Am­s­ter­dam

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.

An­na Abram

“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.

Mark Ab­doo

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 news@raps.org for more in­for­ma­tion.


Zachary Brennan

managing editor, RAPS

John Hood [file photo]

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