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| Korea has made the European Union's (EU) drug whitelist, which is expected to boost the country's medical exports. Korea Times file |
By Bahk Eun-ji
There are expectations that exports of pharmaceutical ingredients will grow after Korea was recently added to the European Union's drug whitelist.
Industry watchers welcomed the listing but also say pharmaceutical companies here must face up to the additional pressure to improve the quality of medicine and quality-control environment to more appeal to European customers.
The Ministry of Food and Drug Safety said Wednesday that Korea has become the seventh outside country to be whitelisted following approval by the European Council, meaning Korea's medicine-related manufacturing and supervision standards are at the same level as those of the EU.
The other six countries on the whitelist are Switzerland, Australia, the United States, Japan, Israel and Brazil.
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| Food and Drug Safety Minister Lee Eui-kyung |
"The EU has strict production and quality rules, such as good manufacturing practice (GMP) in drug manufacturing. Korean companies do not have to submit such written confirmation, as the approval means our quality control standards are equal not only to European countries, but also those of the U.S. and Japan," said Choi Hee-jung, a deputy director at the ministry's Pharmaceutical Quality Division.
"This will be a great opportunity especially for the nation's generic medicine and raw material manufacturers, as demand has increased in Europe for generic treatments due to cost reduction requirements."
The EU is the second-biggest drug market after the U.S., and exports there accounted for 31 percent of Korea's total drug shipments in 2018. The value of exports was $1.4 billion, and of this, shipments of raw materials accounted for $412 million, according to the Korea Pharmaceutical Traders Association.
The ministry expects this recognition will be a huge leap for Korea's drug industry in entering the European market, five years after the country became a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the international authority determines legal standards for the GMP. After acceptance to the PIC/S, the country's total drug exports increased from $2.4 billion in 2014 to $3.1 billion in 2016 and $4.6 billion in 2018.
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| Drugs /gettyimagesbank |
"We express our respect for the ministry's efforts. But as an association of pharmacy manufacturers, we also urge the government and health authorities to prioritize the next hurdle we are facing," the Korea Pharmaceutical and Bio-Pharma Manufacturers Association said in a statement.
The association noted the exemption of submitting documents does not directly promise a boost in exports, considering European consumers are known for their strict standards especially when choosing medicine.
"Improving the quality of medicines and creating an environment for such quality control should come first, and ministry support is required to consolidate the position of Korean medicines globally," it said.
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