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[Press Release, Nov 13, 2020 ] MFDS cooperates with DKMA for information sharing in pharmaceutical sector
  • Registration Date 2020-11-23
  • Hit 875
[Press Release, Nov 13, 2020 / unofficial translation ] MFDS cooperates with DKMA for information sharing in pharmaceutical sector - Signing of MoC expected to accelerate the information exchange on safety management information of pharmaceuticals and medical devices - □ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) announced that it will sign a “Memorandum of Confidentiality on Information Exchange (MOC)” with the Danish Medicines Agency (DKMA) on Nov. 13, 2020 to enhance the bilateral cooperation in the field of pharmaceuticals and medical devices. ○ MFDS and DKMA had concluded an MOU in 2013 as both sides acknowledged the need to improve competencies in the pharmacovigilance and clinical trial fields. ※ Pharmacovigilance: scientific activities for the detection, assessment, understanding and prevention of adverse events or safety-related issues regarding pharmaceuticals ○ The two organizations additionally negotiated the MOC to specify the type of information that can be shared such as data on approval, review, safety, and current situation. The MOC is expected to enable swift and close cooperation in the sharing of information. ○ The signing of the MOC will be held virtually at the Embassy of Denmark in Korea, and the two sides also plan to discuss the details and methods of cooperation with regard to pharmaceuticals and medical devices down the track. □ At the signing ceremony, Minister Kim stated that “amid global health crisis precipitated by the COVID-19 pandemic, the two organizations took a step to further strengthen the bilateral cooperation with an aim to ensure an access to safe and effective pharmaceuticals.”
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  • 1113.식약처, 덴마크 의약품청과 의료제품 분야 정보교환 협력_eng.pdf Download preview

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