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Korea makes list of non-EU countries with EU pharma quality standards

South Korea has been added to the European Commission’s list of countries outside the European Union whose pharmaceutical ingredients and products meet the manufacturing and regulatory standards of the trading bloc, according to the Food and Drug Safety Ministry.

The listing certifies that Korea’s good manufacturing practices comply with the EU’s GMP regulations. 


Countries on the list are exempted from the requirement to submit written confirmation from local regulators that their GMP standards are equivalent to those of the EU when exporting. Korea is now exempt from the written confirmation rule, the Drug Safety Ministry said during a briefing Tuesday.

This exemption will likely widen market access for the Korean pharmaceutical industry, the ministry said, projecting a four-month time savings in the export process. The EU market currently accounts for 31 percent of Korea’s pharmaceutical exports.

Until now, the United States, Japan, Brazil, Australia, Israel and Switzerland were the only countries on the list.

The decision to include Korea was confirmed Tuesday, local time, during an EU Council meeting in Brussels, according to the ministry.

By Kim Arin (