The Asia-Pacific Economic Cooperation (APEC) group recently declared a goal to align regulatory processes for medical devices and pharmaceutical products by 2020. APEC consists of 21 countries, including the US, China, Australia, and South Korea. The initiative is called the “Strategic Framework... Read More
The Korean Food and Drug Administration (KFDA) is in the process of changing its pre-approval system. The plan is to implement the new system partially within this year. The KFDA has presented a draft regulation of this change. Under the proposed new... Read More
The Korea Food and Drug Association (KFDA) recently revised the classification of six medicines. Two over-the-counter (OTC) drugs were re-categorized as prescription drugs, while two previously prescription drugs can now be sold at pharmacies OTC. Classifications of 11 other drugs which consumer... Read More
During the last decade, rates of cancer have increased dramatically in Asia. Asia accounts for nearly half of all new cancer cases in the world. Some cancers that are common in Western countries--such as lung, breast, and colorectal cancers--also are common in... Read More
On June 15, 2011, attempts by Korea’s Ministry of Health and Welfare to ease restrictions on sales of over-the-counter (OTC) drugs fell short as groups representing pharmacists, doctors, consumers, and the government failed to reach an accord. Under South Korea’s Pharmaceutical Law,... Read More
The Free Trade Agreement between South Korea and the European Union (KOREU FTA) has been now been ratified by both parties, paving the way for elimination of tariffs on EU pharmaceutical exports to South Korea. EU pharmaceutical exports are expected to increase... Read More
The US-South Korean Free Trade Agreement (KORUS FTA) is expected to improve the competitiveness of US medical equipment and pharmaceuticals. Once approved by the US Congress, the KORUS FTA will enable more than 90% of US medical equipment exported to South Korea... Read More
Introduction With the United States emerging very slowly from a huge recession, some of Europe unable to pay its bills, and more restrictions coming from the US Food and Drug Administration (FDA), an area where medical device companies may want to focus... Read More
President Obama has declared his intentions to move forward with the Korea – U.S. Free Trade Agreement (KORUS). Written three years ago under President Bush, it includes provisions on the pharmaceutical and medical devices markets. Korean parliament has already passed the deal,... Read More
Korea’s Ministry for Health, Welfare, and Family Affairs (MIHWAF) is planning to implement a new drug-pricing system to address illegal rebate activities in the drug industry. MIHWAF will pay drug stores and medical institutions to buy cheaper drugs. In other words, they... Read More