The Philippines Department of Health is now requiring that most medical devices imported, marketed or manufactured in the archipelago nation be registered with its Food and Drug Administration. The new rules, first telegraphed back in January, are expected to increase costs for... Read More
China’s health insurance regulator in October added 17 anti-cancer drugs to the list of those already covered by its national medical insurance system. The approval of the therapies is part of a series of moves by the government to make cancer treatment... Read More
U.S. pharmaceuticals may stand to gain if revisions to a longstanding trade agreement between the United States and South Korea, announced in September, are approved and implemented. The updates to the U.S.-Korea Free Trade Agreement (KORUS) include a provision to include American... Read More
Moving to counter widespread criticism that its drug supply chain is unsafe and inefficient, Chinese health officials are moving to modernize the nation’s system for tracing pharmaceuticals. In a flurry of recent moves, the China National Drug Administration (CNDA) has posted draft... Read More
The US government is now determining whether Chinese investment into certain industries jeopardizes US intellectual property. In addition to about 25 other industries, biotech companies may now be reviewed by the committee for foreign investment into the US even with respect to... Read More
INTRODUCTION With incomes rising among its rapidly aging population of 96.7 million, Vietnam is a booming market for pharmaceuticals. Long one of the least-developed pharmaceutical markets in Asia, with relatively low per capita spending on drugs, Vietnam has tremendous potential. According to... Read More
As previously reported in February, Vietnam’s registration deadline for Class B, C, and D medical devices had been extended to January 1, 2019. Six months later, that deadline has been pushed back another year, until January 1, 2020. According to Nguyen Tuan... Read More
Seeking to quell confusion over which of its regulatory agencies has purview over medical devices that are used in combination with pharmaceuticals, Malaysia’s Medical Device Administration (MDA) has released guidelines for classifying such products. The combination products, known as Medical Device Drug... Read More
For the first time in a decade, Singapore’s Health Sciences Authority (HSA) is raising the fees it charges to evaluate, register, and license medical devices. The increases, announced in August, are already beginning to take effect. Ranging from $1 to $200 per... Read More
While nearly two dozen medical devices are regulated in India as drugs, they are largely out of government price control, with only five of them subject to specific price caps. Those are cardiac stents, drug-eluting stents, condoms, intra-uterine devices, and, since last... Read More