Archives

Asia is emerging from the global recession faster than other regions in the world. This article goes through some of the major regulatory updates in various Asian countries. Read More

On December 17, 2009, China, Japan, and Korea participated in the second WG meeting on drug clinical trials. This meeting included China’s SFDA, Korea’s Food and Drug Administration (KFDA), and Japan’s Ministry of Health Labor and Welfare (MHLW) and Pharmaceuticals and Medical... Read More

As reported in earlier issues of PBM’s Asian Medical e-Newsletter, Korea’s Ministry of Health has been cracking down on rebates in Korea. On August 1, 2009 the Ministry of Health, Welfare & Family Affairs implemented regulations where drug prices will be reduced... Read More

Plastic surgery is a huge market in South Korea, where double eyelid surgery is a common graduation gift and operations are not limited to just women. Many patients visit South Korea for cosmetic procedures, especially since treatment care can be much less... Read More

Daegu and Osong are two Korean cities that have been selected to accommodate Korea’s new high-tech medical complexes, similar to the bio-tech medical hubs in Boston and in Singapore. This project will cost more than $4.5 billion through 2038, and will be... Read More

The Korean Ministry of Health plans a major crackdown on rebates in the pharmaceutical industry. Rebates are essentially bribes — expensive meals, lavish parties, or rounds of golf — that pharmaceutical companies provide to doctors and hospitals who prescribe and purchase their... Read More

R&D in Asia has the potential to significantly improve the global performance of medical device companies by cutting costs and speeding product development--but extensive due diligence is required for success. Read More

In a move that is likely to ease the way for foreign medical device manufacturers, the KFDA is planning to eliminate certain requirements for certificates of product approval. Manufacturers must currently submit a copy of the product approval in the country of... 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

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