As the global economic crisis deepens, China is entering a new phase in its development. Its exports, economic growth, and employment levels are all falling. It is, however, important for Western businesses to keep these changes in perspective. China's gross domestic product... Read More
There is no doubt that China is and will continue to be a global hotspot for the medical industry. Yet many Western companies that rush haphazardly into China without fully understanding its business culture and mentality ultimately meet with failure. This presentation... Read More
The Korea Food and Drug Administration (KFDA) is undergoing some reorganization. In his second year at his post, Commissioner Yun Yeo-pyo has decided to restructure the KFDA to improve its efficiency and oversight of food, drug, and medical device safety. New divisions... Read More
In February 2009, Thailand’s “Liability for Damages Arising from Unsafe Products Act” came into effect. Drug and device manufacturers selling products in Thailand will need to be aware of the changes in the legal system. Liability of unsafe products will change drastically... Read More
China’s Center for Drug Evaluation (CDE) under the State Food and Drug Administration (SFDA) has recently released statistics for CDE drug registration approval recommendations in 2008. The CDE reviewed over 25,000 applications, including those for clinical trials, import, and production, but rejected... Read More
Differential pricing is a strategy for marketing drugs in India that has often been discussed, but rarely implemented until recently. The term refers to selling patented drugs in India (or other lower-income countries) at lower prices than in developed Western countries. The... Read More
The Korea Food and Drug Administration (KFDA), which has been criticized for a drug registration process that is often not transparent, recently announced efforts to make the process simpler and more comprehensible. According to KFDA officials, the agency has prepared detailed manuals... Read More
Wyeth Pharmaceutical’s recent troubles in India have drawn new attention to the country’s problems enforcing clinical trial standards. In November 2008, an infant died during clinical trials for a Wyeth-manufactured pneumococcal vaccine. This prompted the Drugs Controller General of India (DCGI), India’s... Read More
On January 21, China’s State Council approved the implementation of China’s long-awaited healthcare reform plan. All levels of government will be investing a total of RMB 850 billion (approximately US $124 billion) over the next three years to implement the changes in... Read More
In a surprise move, Indonesia’s Ministry of Health issued a new regulation in November 2008 designed to force foreign companies to manufacture drugs in Indonesia. The regulation states that foreign-owned companies will not be allowed to register imported drugs for sale unless... Read More