EMA／審査関係の更新通知（2026年3月27日付）

2026年3/27付でEMAから審査関係の更新通知が発出されています。

これら通知類は「Regulatory and procedural guideline」などと合せて時折更新されます。

関係者にあっては、「What's New?」ウェブサイト（下記URL）かあるいは個々のタイトルからリンク先をあたってください。

● 「What's New?」ウェブサイト
https://www.ema.europa.eu/en/news-events/whats-new

● 個々の通知類（審査関係のため安全性に関わるものも加えています）

• European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure: document with tracked changes
  https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-pre-authorisation-procedural-advice-users-centralised-procedure-document-tracked-changes_en.pdf
• European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
  https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-pre-authorisation-procedural-advice-users-centralised-procedure_en.pdf
• Transfer of marketing authorisation template - attachment 3
  https://www.ema.europa.eu/en/documents/template-form/transfer-marketing-authorisation-template-attachment-3_en.docx
• Template - Application for transfer of marketing authorisation from transferor to transferee - cover letter (human)
  https://www.ema.europa.eu/en/documents/template-form/template-application-transfer-marketing-authorisation-transferor-transferee-cover-letter-human_en.docx
• European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with tracked changes
  https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-post-authorisation-procedural-advice-users-centralised-procedure-document-tracked-changes_en.pdf
• European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
  https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-post-authorisation-procedural-advice-users-centralised-procedure_en.pdf
• Pre-authorisation guidance
  https://www.ema.europa.eu/en/human-regulatory-overview/marketing-authorisation/pre-authorisation-guidance
• Extensions of marketing authorisations: questions and answers
  https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/variations-including-extensions-marketing-authorisations/extensions-marketing-authorisations-questions-answers
• Type-IA variations: questions and answers
  https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/variations-including-extensions-marketing-authorisations/type-ia-variations-questions-answers
• Type-II variations: questions and answers
  https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/variations-including-extensions-marketing-authorisations/type-ii-variations-questions-answers
• Post-authorisation efficacy studies: questions and answers
  https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/post-authorisation-efficacy-studies-questions-answers
• Grouping of variations: questions and answers
  https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/variations-including-extensions-marketing-authorisations/grouping-variations-questions-answers
• Worksharing: questions and answers
  https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/variations-including-extensions-marketing-authorisations/worksharing-questions-answers
• Type-IB variations: questions and answers
  https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/variations-including-extensions-marketing-authorisations/type-ib-variations-questions-answers
• Post-authorisation safety studies (PASS)
  https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/post-authorisation-safety-studies-pass
• Post-authorisation measures: questions and answers
  https://www.ema.europa.eu/en/pharmacovigilance-post-authorisation/post-authorisation-measures-questions-and-answers
• Periodic safety update reports (PSURs)
  https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/periodic-safety-update-reports-psurs
• Risk management plans (RMP) in post-authorisation phase: questions and answers
  https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/risk-management-plans-rmp-post-authorisation-phase-questions-answers
• Data quality framework for medicines regulation
  https://www.ema.europa.eu/en/about-us/how-we-work/data-regulation-big-data-other-sources/data-quality-framework-medicines-regulation
• Submitting results of paediatric studies
  https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/paediatric-medicines-post-authorisation/submitting-results-paediatric-studies
• Transfer of marketing authorisation: questions and answers
  https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/transfer-marketing-authorisation-questions-answers
• EU implementation strategy of ICH E2D(R1) Guideline - Post-approval safety data: Definitions and standards for management and reporting of individual case safety reports
  https://www.ema.europa.eu/en/documents/scientific-guideline/eu-implementation-strategy-ich-e2dr1-guideline-post-approval-safety-data-definitions-standards-management-reporting-individual-case-safety-reports_en.pdf
• Classification of changes: questions and answers
  https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/classification-changes-questions-answers
• Changing the labelling and package leaflet (Article 61(3) notifications)
  https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/changing-labelling-package-leaflet-article-613-notifications