Managing Asian cultural and business diversity can be very complex for Western companies. Each country has its own culture, history, ideology, language and philosophy: a strategy in Taiwan may not work in China, and vice versa. Understanding the local mentality, beliefs, and... Read More
On June 25, 2008, the Korea Food and Drug Administration (KFDA) drafted a proposal amending current medical device regulations. The KFDA is currently soliciting comments on this proposal until July 16, 2008. The director of the KFDA will announce a “permitted standard,”... Read More
The Korea Food and Drug Administration (KFDA) recently announced plans to increase application fees for drug applications. The KFDA plans to increase fees starting July 1 and then increase the fees again starting January 2009. For New Drug Applications (NDA), the application... Read More
The East Asian Pharmaceutical Regulatory Symposium was recently held April 14-15 2008 in Tokyo. At the Symposium, the Health Ministers of China, Japan and Korea agreed to promote increased clinical data sharing and encourage global drug development. The three Ministers affirmed the... Read More
Korea’s Ministry of Health, Welfare and Family Affairs stated that it would revise regulations and increase support for the medical tourism industry. By October 2008, the ministry plans to revise the current medical law restricting marketing by medical institutions. Medical institutions would... Read More
The Asian Harmonization Working Party (AHWP) has finalized two documents on the Safety Alert Dissemination System (SADS) on January 23, 2008. The main goals of SADS are the following: To define a structure for disseminating medical device safety alerts among AHWP members;... Read More
Asia's growth over the last five years has been phenomenal. China saw at least 10% annual growth in GDP between 2003 and 2006, and India's GDP figures progressed from 7% to 9% over the same period. These countries' medical device markets are... Read More
The Asian Harmonization Working Party (AHWP) had its last meeting on October 26 and 27 in Chengdu, China, where it discussed schedules and plans for the Common Submission Dossier Template (CSDT), Post-market Alert Systems (PMAS) and other tasks. For CSDT and PMAS,... Read More
The Korean Cabinet recently passed a bill to allow the use of clinical trial drugs for patients suffering from serious illnesses having no alternative treatment options. This bill is a revision to the current Pharmaceutical Affairs Law and was approved August 28,... Read More
When registering a medical device in Korea, an applicant must demonstrate Korean GMP (KGMP) compliance. Previously, under the Pharmaceutical Affairs Act, foreign manufacturers could demonstrate KGMP compliance with an ISO 1348:2003 or US FDA QSR certification. Also, KFDA audits only applied to... Read More