EMA／欠品緩和と予防計画に関するガイドライン等（2025年5月13日付）

5/13付でEMAからEuropean Shortages Monitoring Platform (ESMP)関係の更新文書等が多数発出されています。

また本件について、5/15付のRAPSがEuro Roundup内に「EMA updates Q&A on drug shortage platform’s submission and reporting requirements」と題して記事に取り上げています。

また、5/16付のGMP Verlagが「EMA: FAQs on the European Shortages Monitoring Platform (ESMP)」と題して記事に取り上げています。

あくまでEU圏内での欠品問題ですが、本邦にも参考にできる点があるかもしれませんので、薬業界における情報としてお伝えしておきます。

関係者および興味のある方は、下記URLsの新規ならびに更新通知等をご参照ください。

• 5/13付EMA「European Shortages Monitoring Platform (ESMP) essentials: Industry and network reporting requirements」
  https://www.ema.europa.eu/en/documents/other/european-shortages-monitoring-platform-esmp-essentials-industry-network-reporting-requirements_en.pdf
• 5/13付EMA「European Shortages Monitoring Platform (ESMP) Informational brief」
  https://www.ema.europa.eu/en/documents/other/european-shortages-monitoring-platform-esmp-informational-brief_en.pdf
• 5/13付EMA「Frequently asked questions on the European Shortages Monitoring Platform (ESMP)」
  https://www.ema.europa.eu/en/documents/other/frequently-asked-questions-european-shortages-monitoring-platform-esmp_en.pdf
• 5/13付EMA「European Shortages Monitoring Platform (ESMP): Implementation guide for national competent authorities」
  https://www.ema.europa.eu/en/documents/other/european-shortages-monitoring-platform-esmp-implementation-guide-national-competent-authorities_en.pdf
• 5/13付EMA「European Shortages Monitoring Platform (ESMP) User guide for national competent authorities」
  https://www.ema.europa.eu/en/documents/other/european-shortages-monitoring-platform-esmp-user-guide-national-competent-authorities_en.pdf
• 5/13付EMA「European Shortages Monitoring Platform (ESMP) User guide for marketing authorisation holders」
  https://www.ema.europa.eu/en/documents/other/european-shortages-monitoring-platform-esmp-user-guide-marketing-authorisation-holders_en.pdf
• 5/13付EMA「European Shortages Monitoring Platform (ESMP): Marketing authorisation holder reporting templates」
  https://www.ema.europa.eu/en/documents/template-form/european-shortages-monitoring-platform-esmp-marketing-authorisation-holder-reporting-templates_en.xlsx
• 5/13付EMA「European Shortages Monitoring Platform (ESMP): Implementation guide for marketing authorisation holders」
  https://www.ema.europa.eu/en/documents/other/european-shortages-monitoring-platform-esmp-implementation-guide-marketing-authorisation-holders_en.pdf
• 5/13付EMA「European Shortages Monitoring Platform (ESMP): National competent authority reporting templates」
  https://www.ema.europa.eu/en/documents/template-form/european-shortages-monitoring-platform-esmp-national-competent-authority-reporting-templates_en.xlsx
• 5/15付RAPS／Euro Roundup「EMA updates Q&A on drug shortage platform’s submission and reporting requirements」
  https://www.raps.org/News-and-Articles/News-Articles/2025/5/Euro-Roundup-EFPIA-calls-on-EU-to-support-EMA-AI-s
• 5/16付GMP Verlag「EMA: FAQs on the European Shortages Monitoring Platform (ESMP)」
  https://www.gmp-publishing.com/content/en/gmp-news/news-about-gmp-cgmp/d/ema-faqs-on-the-european-shortages-monitoring-platform-esmp