As Asian countries begin to adopt more western lifestyles and foods, “western” diseases are becoming more prevalent killers in Asia. Economic transition, urbanization, and technological development have brought about lifestyle changes that have increased the chances for heart disease in Asia. Developing... Read More
This article covers some of the changing dynamics of the regulatory scene in Asia for pharmaceuticals and medical devices, with information and updates from China, Korea, Japan and Taiwan. Drug prices and reimbursement rates have been cut as governments take steps to... Read More
The battle between multinational pharmaceutical manufacturers and the South Korean government continues as the proposed “reference pricing system” moves forward. The reference pricing system, which plans to cut current reimbursement rates for medical treatment in Korea, will have a considerable effect on... Read More
The South Korean government announced the passing of a new bill banning the cloning of human cells starting next year. The bill that was finalized on September 24, 2002, will restrict the cloning of human cells as well as somatic cells. The... Read More
The main regulatory body in charge of overseeing medical devices in South Korea is the Korea Food & Drug Administration (KFDA) established in 1996. Through the Medical Devices & Radiation Health Department, the KFDA performs inspections and quality assurance as well as... Read More
South Korea’s Ministry of Finance and Economy recently announced their plans to develop five Special Economic Zones (SEZs) throughout the country. The plan is part of the Korean government’s endeavor to attract greater foreign investments into the country. Besides special tax incentives... Read More
Slowing economies have not stopped Asian countries from moving ahead with medical device regulatory reforms. Asian consumers demand high-quality healthcare products, making it worthwhile for American manufactures to be active in the region. Procedures and practices vary according to country. This article... Read More
Controversy has arisen between US drug manufacturers and the Korean government regarding the reform of South Korea’s national health insurance system and its affects on drug pricing. Proposals have been made by Korea’s Health Ministry to implement a new reference pricing system... Read More
Before medical devices can be manufactured or sold in South Korea, it must first obtain the approval of the Korea Food & Drug Administration (KFDA). Through a system of testing, the KFDA would reject or approve the manufacture or sale of a... Read More
Less than two years ago, the Korean government significantly revamped rules governing the prescription and sale of pharmaceuticals in that country. Prior to the reform, distinct roles between those who prescribed and sold drugs were not clearly defined. Doctors and pharmacists could... Read More