European Commission Confirms Quality of South Korean Active Substances

Regulatory NewsRegulatory News | 15 May 2019 |  By 

The European Commission this week confirmed that the quality of active substances produced in the Republic of Korea are in line with EU standards.

South Korea joins Australia, Brazil, Israel, Japan, Switzerland and the US as countries outside of the EU that have been established as manufacturing active substances in an EU-equivalent regulatory system with sufficient rules for good manufacturing practices.

“Third countries can ask the Commission to assess whether their regulatory framework and the respective control and enforcement activities ensure a level of protection of public health equivalent to that of the Union. The Ministry of Food and Drug Safety (MFDS) of the Republic of Korea requested such an assessment in 2015,” the commission said.

Following a successful review of relevant documentation from the MFDS, and after two audits conducted by the European Commission in 2016 and 2018, this week’s decision confirms that South Korea’s legislative framework applicable to active substances is capable of ensuring a level of protection of public health equivalent to that of the EU.

Commission Implementing Decision


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