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KCI등재 학술저널

미국, 유럽, 일본의 레지스트리 구축 등 데이터기반 의료제품의 안전관리 동향

Current status and examples of patient registries in the US, Europe, and Japan and proposal of planning patient registry in Korea

DOI : 10.17480/psk.2020.64.5.358
  • 151

Over the past years regulatory agencies of Europe, the United States, and Japan have announced policies to facilitate the establishment and utility of registries at the national level in order to enhance post-marketing surveillance. With the recent increase in medical products safety issues, the Ministry of Food and Drug Safety (MFDS) is planning to build a patient registry system to monitor the safety of problematic products. The objective of this study is to examine the initiatives and the activities of health authorities in the US, Europe, and Japan and identify the essential features of well-operated registries. We collected information from official documents and postings on the health authority’s homepages about activities and efforts of the initiatives. We also surveyed and analyzed the official reports, the guide for each stakeholder of registries, and the information sheets for patients or doctors as case studies of well-designed registries. Therefore, this study suggests future directions on how to plan a long-term follow-up system and on how to design national level registries in Korea.

서 론(Introduction)

연구 방법(Research Methods)

결 과(Results)

고 찰(Discussion)

결 론(Conclusion)

References

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