Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

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[Press Release, Oct, 20] Strengthening cooperation between Korea and Denmark in sharing clinical trial data on pharmaceutical products
  • Registration Date 2020-11-03
  • Hit 12704
[Press Release, Oct, 20 / Unofficial translation] * Correction for mistyping of Acronym, from DHMA to DKMA (dated on Nov. 20) Strengthening cooperation between Korea and Denmark in sharing clinical trial data on pharmaceutical products - MFDS-DKMA, holding Clinical Trial Online Workshop □ The Ministry of Food and Drug Safety (MFDS, Minister Lee Eui-Kyung) stated that bilateral Clinical Trial Online Workshop will be held on October 20 to strengthen the cooperation with Danish Health and Medicines Authority (DKMA) by discussing the improvement measures for clinical trial sector and sharing related information. ○ The MFDS and the DKMA are ahead of signing “Memorandum of Confidentiality on Information Exchange (MOC)” next month for the cooperation in pharmaceutical product and medical device sectors. Accordingly, the Workshop would have a great meaning as the starting point of a close cooperation between two countries. □ The main contents that will be discussed in the workshop are ▲the direction and introduction of the clinical trial policy from the two countries, ▲the exchange of clinical trial improvement measures in response to the COVID-19 pandemic situation. ○ In particular, regulatory authorities from all over the world have been contemplating alternatives due to unexpected limitations on conducting clinical trials such as the limitations of quarantine activities or movement. - Amid this situation, the workshop is expected to be a great opportunity to compare the policies from the two countries as a reference for the preparation of domestic policy improvement measures. □ The MFDS stated that it will actively interact with foreign regulatory authorities to improve clinical trial sectors including the development of COVID-19 treatments/vaccines and new drugs and support clinical trials to be carried out in safe and swift manner amid the COVID-19 situation.
Attached File
  • (10.20) 한·덴마크, 의약품 임상시험 정보교류 등 협력 강화_eng_수정.pdf Download preview

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