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Ministry to help Korean products gain U.S. FDA approval

The government is planning to support 41 health and cosmetics companies’ advancement into the U.S. market.

The “Columbus Project,” to be funded by the ministry and other related agencies, aims to help Korean firms increase their share of the U.S. market from the current 1.1 percent to 3.4 percent by 2015, the Ministry of Health and Welfare said Thursday.

The 41 companies include some household names such as the Green Cross, Daewoong, Celltrion, Korea United, Hanmi, SK Chemical and Yuhan Corporation in pharmaceuticals; Medison, AhnGook and Osstem Implant in medical equipment; and Nadri, Amore Pacific and LG Household and Health Care in cosmetics. They also include venture firms including Taejoon, CU and TaeWoong.

Some of the companies have already tried to break into the U.S. market. The selected companies will be able to receive “fast-track” consultations on the legal procedures for gaining the U.S. Food and Drug Administration’s certificates and other necessities. If needed, the government will deregulate domestic certification procedures, Health Ministry officials said.

The ministry will support the companies to participate in the “BIO US 2011” in Washington in June and exempt them from the participation fee for the BIO KOREA to be held later this year in Seoul.

“LG Life Science has had by far the most significant success in the market ― it is on the verge of being certified with a new drug by the FDA. Making it in the U.S. market is very hard,” said Chung Eun-kyoung, a ministry official.

Chung said even after gaining the FDA approval, a substantial amount of money is needed for marketing and other uses.

“The Columbus Project will help the companies focus on the development of novel drugs and their sales while the government helps with the paperwork,” she added.

According to the Korea Food & Drug Administration, Korea exported 1.5 trillion won worth of health-technology equipment in 2009, about 21.7 percent up from the previous year.

By Bae Ji-sook (baejisook@heraldcorp.com)
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