Moving from in principle to in practice: The FDA, EMA inspection pilots
When it comes to inspections, collaboration and info-sharing helped FDA and international regulators cover more ground globally, the agency said in a report on two pilot projects it conducted with its European and Australian counterparts.
The two pilots, one focused on clinical trial inspections and the other on API manufacturers, were designed to test feasibility—and work out some of the kinks—of a more cooperative inspection model that FDA has put at the center of its new comprehensive plan to catch up with demands of watch-dogging the global drug supply. They were conducted between December 2008 and March 2011.
FDA said it was able to cut down on redundant inspections by relying on shared reports, and could better flag factories or trial sites that should be checked sooner, versus ones that could wait. Such basic risk assessment in a resource-intensive operation like field inspection is sorely needed. FDA noted that it banned the import of a product based on a negative European inspection. Concrete actions like that are strong evidence that this cooperation really worked, and that’s a good thing.
While they cover some predictable ground, the reports offer a close look at the nuts and bolts of what info-sharing and joint inspections really require – the fine balance of having enough teleconferences vs. too many, planning joint inspections far enough in advance so everyone you want to be there can be there, and the eternal question: Should we put this in an Excel sheet? But inspections are nothing if they aren’t about the details—and about getting them right.
All told, these pilot projects offer good evidence that the FDA’s move toward sharing its regulatory burden is both a workable and wise one.
But big roadblocks still exist. One of the challenges these agencies still face is how to best work with inspectors in countries with newer or less-developed regulatory cultures—countries such as India and China that are also the site of more and more ingredients manufacture and clinical trials. For instance, FDA’s Deborah Autor pointed out at the Pew Health Group’s After Heparin meeting that before inspecting factories in some countries like China, agencies are required to have a written invitation from the government to obtain a visa.
“All partners are supportive in principle of continuing the API inspection collaboration and extending the project to new partners,” the report says, but of course there are often miles to go between ‘in principle’ and ‘in practice.’
And these pilots move the US, Europe and Australia down the ‘in practice’ field.
You can download the reports at FDA’s site.
–Kate Petersen, PostScript blogger