CPhI: As Covid-19 re­stric­tions ease, an in­spec­tion back­log could have a big ef­fect on new drugs, gener­ics

Like the me­chan­ics in a clock, phar­ma man­u­fac­tur­ing of­ten qui­et­ly ticks away un­til one piece of the ma­chine hits a snag. Now, as part of its an­nu­al check-in on the in­dus­try, CPhI is high­light­ing a grow­ing back­log of man­u­fac­tur­ing in­spec­tions for­eign and do­mes­tic to the US as a po­ten­tial­ly ma­jor snag in the gears.

To bat­tle sup­ply chain is­sues, the US has en­cour­aged an in­crease in do­mes­tic pro­duc­tion, which has not been easy or con­sis­tent. Nielsen Hobbs, In­for­ma Phar­ma In­tel­li­gence’s ex­ec­u­tive ed­i­tor of US pol­i­cy and reg­u­la­tion, says the biggest chal­lenge fac­ing man­u­fac­tur­ers go­ing for­ward could be in­spec­tions from reg­u­la­tors. A hia­tus has last­ed over a year, as trav­el has been re­strict­ed, but that is over­due to end.

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