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
The Asian Harmonization Working Party (AHWP) has recently drafted a post-marketing system to harmonize medical device adverse event reporting. AHWP members have varied systems for adverse event reporting, and some have no system at all. The new draft document aims at reducing... Read More
After 10 months of lengthy discussions and meetings, South Korea and the United States have finally wrapped up an epic free trade agreement. Among the various industries, the FTA also included provisions on the pharmaceutical and medical devices markets. Among these provisions... Read More
With steadily increasing drug development costs and significant time spent on clinical trials, outsourcing clinical trials in Asia has rapidly become an appealing option for many firms. As developing a single drug can cost more than $200 million and take at least... Read More
The Korea Food & Drug Administration (KFDA) recently announced that 22 drug substances would be subject to drug master file (DMF) registration by the end of 2007. Any imports of these drug substances or products containing one or more of these 22... Read More
Korea is an important Asian destination for foreign medical devices. Its total medical device market in 2005 was about $2.5 billion. While this may seem low compared to China's $5 billion, its health expenditure per capita in 2006 was $705, compared to... Read More
The Asian Harmonization Working Party (AHWP) has recently drafted a “Common Submission Dossier Template” (CSDT). If adopted, this would allow medical device companies to use one common form when submitting to any of the 13 countries in the AHWP. By adopting this... Read More
While orphan drug laws in Asia may provide benefits for companies registering new drugs, such as marketing exclusivity, an expedited registration process, and a reduction in the number of clinical trials required, each registration process is unique and can pose a variety... Read More
The Korean Ministry of Health and Welfare has announced that it will implement price cuts on drugs produced by foreign pharmaceutical companies. In addition to cutting drug prices, the government also cut the number of drugs that are covered by insurance, only... Read More