South Korea makes EU drug standard whitelist

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South Korea makes EU drug standard whitelist

A laboratory of Korean biopharmaceutical company Celltrion in Songdo, Incheon. Courtesy of Celltrion

South Korea has made the European Union's (EU) drug whitelist, which is expected boost the country's medical exports going forward, the Seoul government said Wednesday.

The country has been added to the list of non-EU countries that have been determined to have medicine-related manufacturing and supervision standards on par with member states of the political and economic union, according to the Ministry of Food and Drug Safety. The decision was reached by the European Council in Brussels on Tuesday (local time).

"Asia's fourth-largest economy is the seventh country, after Switzerland, Australia, Japan, the United States, Israel and Brazil, to get an exemption from having to submit written confirmation that the medicine being shipped to the EU meets strict production and quality rules," the ministry said.

It said this recognition means that Seoul's good manufacturing practice (GMP) in drug manufacturing and the quality control standards maintained by local pharmaceutical companies are equal not only to European countries, but that of the U.S. and Japan.

A pharmacy in Korea. Yonhap

"Getting on the whitelist can reduce the time it takes to ship drugs by around four months, which can help with overall exports and promote growth of the industry as a whole," the drug safety regulator said.

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

Meeting Europe's GMP standard comes after the country first applied for exemption in January 2015, and some five years after it became a member of the international Pharmaceutical Inspection Co-operation Scheme (PIC/S).

Getting accepted to both standards shows the headway made by South Korea in the pharmaceutical sector over the years and its growing presence on the world stage.

South Korea's total drug exports, following acceptance to PIC/S, have been rising steadily from $2.4 billion in 2014 to $3.1 billion in 2016 and to over $4.6 billion last year, it said. (Yonhap)


A laboratory of Korean biopharmaceutical company Celltrion in Songdo, Incheon. Courtesy of Celltrion

South Korea has made the European Union's (EU) drug whitelist, which is expected boost the country's medical exports going forward, the Seoul government said Wednesday.

The country has been added to the list of non-EU countries that have been determined to have medicine-related manufacturing and supervision standards on par with member states of the political and economic union, according to the Ministry of Food and Drug Safety. The decision was reached by the European Council in Brussels on Tuesday (local time).

"Asia's fourth-largest economy is the seventh country, after Switzerland, Australia, Japan, the United States, Israel and Brazil, to get an exemption from having to submit written confirmation that the medicine being shipped to the EU meets strict production and quality rules," the ministry said.

It said this recognition means that Seoul's good manufacturing practice (GMP) in drug manufacturing and the quality control standards maintained by local pharmaceutical companies are equal not only to European countries, but that of the U.S. and Japan.

A pharmacy in Korea. Yonhap

"Getting on the whitelist can reduce the time it takes to ship drugs by around four months, which can help with overall exports and promote growth of the industry as a whole," the drug safety regulator said.

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

Meeting Europe's GMP standard comes after the country first applied for exemption in January 2015, and some five years after it became a member of the international Pharmaceutical Inspection Co-operation Scheme (PIC/S).

Getting accepted to both standards shows the headway made by South Korea in the pharmaceutical sector over the years and its growing presence on the world stage.

South Korea's total drug exports, following acceptance to PIC/S, have been rising steadily from $2.4 billion in 2014 to $3.1 billion in 2016 and to over $4.6 billion last year, it said. (Yonhap)


Ko Dong-hwan aoshima11@koreatimes.co.kr


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