Man­u­fac­tur­ing roundup: FDA, Swissmedic ink deal on phar­ma GMP; SK biotech con­tracts with Charles Riv­er for RNA ther­a­py 

The reg­u­la­to­ry agen­cies of the US and Switzer­land signed an agree­ment last week, al­low­ing them to uti­lize each oth­er’s good man­u­fac­tur­ing prac­tice (GMP) in­spec­tions of phar­ma­ceu­ti­cal man­u­fac­tur­ing fa­cil­i­ties — and by­pass du­pli­cate in­spec­tions.

This is the newest agree­ment that the FDA has with for­eign en­ti­ties, such as the EU and the UK. These agree­ments are thanks to a 2012 law that al­lowed the FDA to rec­og­nize in­spec­tions con­duct­ed by cer­tain for­eign reg­u­la­tors de­ter­mined to be ca­pa­ble of in­spec­tions that met US re­quire­ments.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.