EU lists Korea on drug standard whitelist

Lee Han-soo  Published 2019.05.15  13:25  Updated 2019.05.15 13:25


Korea's medical export to the European Union is expected to see strong growth as the nation has recently become the seventh country to make the EU's drug whitelist, officials said Wednesday.

The designation came more than four years after Seoul applied for exemption in January 2015.

According to the Ministry of Food and Drug Safety, the country has been added to the list of non-EU countries as the European Council in Brussels determined that Korea's medicine-related manufacturing and supervision standards are on par with EU member on Tuesday.

The existing six countries on the EU whitelist are Switzerland, Australia, Japan, the U.S., Israel, and Brazil.

"The recognition means that Korea's good manufacturing practice (GMP) in drug manufacturing and the quality control standards are equal to those of European countries, the U.S. and Japan," the ministry said. With the approval, Korean pharmaceutical companies will be exempt from specific paperwork when exporting pharmaceutical products and ingredients to the EU.

The ministry expects that it will boost the country's export of pharmaceutical products as the approval will save up to four months in the export process. It based such expectations on the fact that the nation's export to the EU increased significantly after the country became a member of the International Pharmaceutical Inspection Co-operation Scheme (PIC/S) in 2014.

Korea's drug exports to the EU reached hit $1.4 billion in 2018, accounting for 31 percent of the country's total for the year.

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