Japan and the US have begun negotiating a mutual recognition agreement covering GMP inspections of pharmaceutical manufacturing plants, a step that could ease the regulatory burden on drug makers exporting between the two countries. Under such a deal, US and Japanese regulators... Read More
On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a substantial increase in unannounced inspections at foreign manufacturing facilities that manufacture medical products for U.S. import. This initiative is a result of a White House Executive Order directing agencies... Read More
Recently, The Asia Pacific Medical Technology Association (APACMed) released their position paper titled “Risk-based Change Management for Registered Medical Devices.” As noted in this paper, some Asian countries utilize risk-based methods for device changes, while others require change submissions no matter what... Read More
Currently, in the US House and Senate, a potential BIOSECURE Act is on the table. This Act while not finalized or implemented yet, will likely affect US drug and biotech companies and their relationships with China (and to a much lesser extent our... Read More
The COVID-19 pandemic is hampering the initiation and progress of clinical trials in Asia and around the world. Few patients are entering studies, and trials of new treatments are on hold. In Korea, the number of new patients enrolling in clinical... Read More
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With U.S. medical personnel and institutions facing key supply shortages in fighting the COVID-19 virus outbreak, trade officials in March removed tariffs on dozens of medical items imported from China. The tariff exemptions on face masks, exam gloves, surgical drapes, protective gowns,... Read More
As the use of artificial intelligence (AI) takes hold in Asia’s healthcare industry, researchers are collecting detailed health profiles of citizens and using the data to test treatments, monitor adverse drug reactions in patients, detect the risk of cognitive issues in children... Read More
The Trump administration will exempt certain categories of medical devices and medical equipment from hefty tariffs it slapped on $34 billion of Chinese imports to the U.S., offering relief to some U.S, firms. The narrow list of exemptions will provide relief from... Read More