Seo Jin-woo and Minu Kim
South Korea has been added to the list of non-EU countries whose medicine-related manufacturing and quality control standards are recognized as on par with EU member states, a fast-track move that can shorten delivery time of Korean active pharmaceutical ingredients (APIs) to the EU market by around four months, the Seoul government said Tuesday.
The Ministry of Food and Drug Safety said the European Council in Brussels gave a whitelist status to South Korea, exempting it from submitting written confirmation that medicines being shipped to Europe meet good manufacturing practice (GMP) standards.
South Korea became the seventh country after Switzerland, Australia, Japan, the United States, Israel and Brazil to get the exemption from the EC. Imported APIs need written confirmation to guarantee GMP standards required in the EU directives or other equivalent.
The exemption means that Seoul’s GMP system and quality control standards at domestic pharmaceutical firms are equal not only to European countries, but also that of the U.S. and Japan, the ministry said, adding more than four months can be saved in the shipment of local APIs to the EU under the whitelist system established in Nov. 2012.
Europe accounts to be the largest pharmaceutical market after the U.S. and represents 31 percent of Korean medicine exports. Getting on the whitelist will boost Korea’s overall medicine exports to the EU and elsewhere and promote the growth of its pharmaceutical industry as a whole, the ministry expected.