EC confirms: Korean APIs in line with EU standards
On 14 May 2019, the European Commission confirmed that the quality of APIs produced in the Republic of Korea is in line with EU standards. APIs manufactured in third countries like the Republic of Korea, and intended for the EU market, have to be produced in an EU equivalent regulatory system. This includes the rules for GMP.
The application of Korea for an equivalence assessment goes back to January 2015. Since then, a review of the relevant documentation submitted by the South Korea’s Ministry of Food and Drug Safety (MFDS) took place, along with two audits by the Commission in 2016 and 2018.
South Korea joins Australia, Brazil, Israel, Japan, Switzerland and the US as adopted countries outside the EU.
EC: Public Health
EC: Listing of Third Countries