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 pollicy 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.