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  • [Reporter¡¯s View] Deleting exemptions for industry dev.
  • by Lee, Jeong-Hwan | translator Alice Kang | Apr 7, 2022 06:10am
Deletion of the special exemption regulation provided for drugs listed on the foreign drug formulary
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 health insurance finances
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