As part of the first phase of a broader trade pact signed by Chinese and U.S. officials in January, China has agreed to enact a system to prevent infringement of drug patents, a move that may boost protections for branded drugs in... Read More
Major new safety regulations set to take effect in South Korea in August include priority screening of biopharmaceuticals designed to treat rare diseases, The new safety regulations, instituted in the wake of a series of pharmaceutical safety scares, for the first time... Read More
Fueled by a lack of access to preventative eye care and a dearth of public vision screening programs, myopia, and other ophthalmologic conditions are on the rise in East Asia. In one city in China, a 15-year study completed in 2015 found... Read More
After two years of delays, Taiwan’s legislature in January passed legislation establishing dedicated regulations on medical devices. The Medical Device Management Law, which has not yet been signed by Taiwan’s president, separates the regulation of medical devices from pharmaceutical products in the... Read More
To view these presentation slides, please click on DMF Registration in China. Read More
As China’s drug market grows exponentially, more foreign API, excipient and drug packaging material companies look to sell their products in China. In August 2016, to simplify the drug review procedure, the former CFDA announced that the review and approval of APIs,... Read More
Systematic evaluations of the effects of health technologies in Japan, China, and South Korea conducted over the past three years are showing success in determining the clinical benefits and cost-effectiveness of widely used drugs, adjusting pricing of drugs and medical devices and... Read More
Seeking to more effectively manage, distribute and ensure the efficacy of publicly funded vaccines, Chinese health authorities plan to institute a web-based national vaccine tracking system in the next three months. The system, piloted in seven major provinces last year, is designed... Read More
New drug therapies to treat serious and life-threatening diseases would be reviewed more quickly under draft regulations under consideration by China’s Center for Drug Evaluation (CDE). The proposed guidelines would allow for priority review and conditional approval of pharmaceuticals deemed to have... Read More
One month after the Philippines health authorities recommended capping retail prices of 120 needed drugs that are more costly in the archipelago nation than on average elsewhere, major pharmaceutical companies are in talks to reduce prices on some drugs voluntarily. In a... Read More