Until now, the pharmaceutical authorities had partially exempted the safety and efficacy review for ETCs and OTCs listed on drug formularies of 8 advanced countries – the US, Japan, UK, Germany, France, Italy, Switzerland, and Canada - for the prompt introduction of drugs to Korea.

This special exemption system for drugs listed in foreign drug formularies was introduced and operated to promote domestic drug approval and production in 1970 in consideration of Korea’s relatively low drug development capabilities then.

For the past several years, the system has been repeatedly criticized for impeding the development of the pharmaceutical industry and increasing unnecessary waste of h