Press Release, 24 April 2017 (Mon)

□ The Ministry of Food and Drug Safety announced that the Ministry published the “Guide to Drug Approval System in Korea” to promote the Korean regulatory framework for drug approvals.
- The interest for the Korean regulatory system on the drug approval has been internationally increased after the MFDS joined as an ICH member last year. In order to meet the needs, the MFDS published the ”Guide to Drug Approval System in Korea“ in English.
※ The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an International association bringing together the regulatory authorities and pharmaceutical industry to develop ICH Harmonized Guidelines via a process of scientific consensus. The MFDS joined the ICH Association as a member on November 9, 2016.
- The Guide consists of the general information on the Korean pharmaceutical regulatory system as follows:
1) Pharmaceutical laws and regulations; 2) Classification of pharmaceutical products; 3) Drug approval system 4) Required dossiers for drug approval; and 5) Fees, etc.

□ The MFDS expects that the Guide will help promote the Korean regulatory system globally, strengthening the competitiveness in its pharmaceutical industry.
- The Guide is provided to both domestic and overseas pharmaceutical industry and foreign embassies and consulates in Korea. This Guide is available at the MFDS English website: (www.mfds.go.kr/eng)

Contact
Drug Review Management Division
Deputy Director Kim Eunhee (☎ +82-43-719-2876)