[Twenty-year History and Future Challenges in Transparency Enhancement of Review Process for Approval: Focus on Public Release of Review Reports regarding New Drugs and Medical Devices].
[Twenty-year History and Future Challenges in Transparency Enhancement of Review Process for Approval: Focus on Public Release of Review Reports regarding New Drugs and Medical Devices].
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增强审评流程透明度的二十年历程与未来挑战：聚焦新药医疗器械审评报告的公开发布
DOI：
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发表时间：
2015
期刊：
影响因子：
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通讯作者：
Yasunori Yoshida
中科院分区：
文献类型：
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作者：
Kazushige Morimoto;Satoko Kawasaki;Yasunori Yoshida
20年来，厚生劳动省（MHLW，前身为厚生省（MHW））一直在努力提高审批报告审查程序的透明度，以促进新批准的药品和医疗器械的合理使用。 MHW 于 1994 年发布了第一份批准依据摘要 (SBA)。1999 年，MHW 和药品和医疗器械评估中心编写了评估报告，并向公众提供。 2005年，药品医疗器械厅（PMDA）行政长官发出通知，规定了新药申请审查信息的公开程序。 2006年，PMDA网站上公布了90个新批准药品和8个医疗器械的审评报告。研究了美国食品药品管理局 (FDA) 和欧洲药品管理局 (EMA) 的信息传播情况，并与 MHLW 和 PMDA 的信息传播情况进行了比较。虽然 PMDA 已发布新药的通用技术文件 (CTD) 和新医疗器械的摘要技术文件 (STED)，但 FDA 和 EMA 尚未发布此类文件。欧洲公共评估报告（EAPR）针对公众的摘要是一种有趣的问卷调查方法，使用“什么”、“如何”和“为什么”格式。最后，还概述了未来十年的未来建议。
For 20 years, the Ministry of Health, Labour and Welfare (MHLW, formerly Ministry of Health and Welfare (MHW)) has been trying to increase transparency of the review process for approving reports in order to promote the rational use of newly approved drugs and medical devices. The first Summary Basis of Approval (SBA) was published by MHW in 1994. In 1999, evaluation reports were prepared by MHW and the Pharmaceuticals and Medical Devices Evaluation Center to make them available to the public. In 2005, a notice from the Chief Executive of the Pharmaceuticals and Medical Devices Agency (PMDA) made procedures for public release of information on reviewing applications for new drugs. In 2006, 90 review reports of newly approved drugs and eight medical devices were revealed on PMDA websites. The dissemination of information by the United States Food and Drug Administration (FDA) and that of the European Medicines Agency (EMA) were studied and compared with that of the MHLW and PMDA. While common technical documents (CTD) for new drugs and summary technical documents (STED) for new medical devices have been released by PMDA, such documents are not released by the FDA and EMA. The European Public Assessment Report (EAPR) summary for the public is an interesting questionnaire approach that uses the "What," "How" and "Why" format. Finally, future proposals for the next decade are also outlined.