Archives

img-01

More Unannounced FDA Inspections in China and India

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

img-01

China Medical Device Update

On May 13, China’s NMPA promulgated a new list of medical devices exempt from clinical trials. This new list, an update to the 2023 list, identifies 27 medical devices, including seven Class 3 products and 20 Class 2 products. In total, 1047 medical... Read More

img-01

Drug GMP Systems in China, Japan, and Korea

In the international pharmaceuticals industry, Good Manufacturing Practice (GMP) compliance is a fundamental foundation for the safety, quality, and efficacy of drugs. With expanding supply chains and more complex global partnerships, knowledge of the quality compliance environments of leading Asian pharmaceutical markets... Read More