Delegation of the European Union to Armenia

Korea enlisted in the EU for active pharmaceutical ingredients

Seoul, 16/05/2019 - 08:57, UNIQUE ID: 190516_7
Press releases

On May 14, the European Commission decided to add the Republic of Korea to the list of third countries considered equivalent with the EU on the standards of good manufacturing practice and quality control of manufacturing sites for active pharmaceutical ingredients (API).

According to the Falsified Medicines Directive, third countries may request the Commission to assess their regulatory framework applicable to APIs exported to the EU, and whether its respective control and enforcement activities are in the ensuring level of public health protection to those of the EU. Third countries considered to have equivalent standards and supervision, will be exempted from issuing written confirmation on the API manufacturer's audits, which will enable the exporting country to streamline the exporting process.

Being a member of the international pharmaceutical inspection  Co-operation Scheme (PIC/S), Korea applied for the listing on January 2015 and after the four-year evaluation, the Commission concluded the assessment and audits to be satisfactory. Korea is the seventh country to be enlisted after Switzerland, Australia, Japan, the United States, Israel and Brazil.


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