China’s National Medical Products Administration (NMPA) has issued guidance governing online sales of medical devices with a focus on inspections of the products’ manufacturing facilities. The agency made it clear that the manufacturer will have to deal promptly with any deviations from the regulations or face enforcement action, signaling a new era of tighter scrutiny of online sales of these products.

The U.S. FDA’s final guidance for clinical trial inspections conducted under the bioresearch monitoring (BiMo) program seems to deviate little if at all from the 2024 draft, but that is precisely the rub for some stakeholders. The Advanced Medical Technology Association pressed the agency to ensure that the final guidance takes into account the hazards of electronic access during remote BiMo audits, but the final guidance makes no such concessions.

The U.S. FDA’s recent switch toward more routine use of generalist field investigators might be seen in some quarters as an attempt to do more with less, but a session on the topic at the Food and Drug Law Institute’s annual enforcement conference in Washington seems to suggest that this reversal of historic practice presents at least as many problems as solutions for industry.

The lingering effects of the COVID-19 pandemic and ongoing recruitment/retention issues are making it difficult for the U.S. FDA’s bioresearch monitoring program to keep up with the on-site clinical research inspections that are a cornerstone of the preapproval process for new drugs, biological products and medical devices. The resulting delays could threaten the approval timelines for many products.

The COVID-19 pandemic took a huge bite out of the U.S. FDA’s ability to conduct inspections in a timely manner, but the FDA’s Douglas Stearn said the agency has nonetheless ramped up these activities.