《更新》英国MHRA／リフォームした臨床試験に絡んでの通知更新（2026年4月28日付）

※初出掲載 （2026.04.28）
※追記更新 （2026.05.07）

4/27日付GMP Platformトピック「英国MHRA／リフォームした臨床試験の開始」としてお伝えした「Launch of clinical trial reforms」に絡んで、4/28付で多数の通知が発出されています。

関係者および興味のある方は、下記URLsの通知をご参照ください。

• 「Clinical trials for medicines: Clinical Trials Regulations transitional arrangements」
  https://www.gov.uk/guidance/clinical-trials-for-medicines-clinical-trials-regulations-transitional-arrangements
• 「Clinical trials for medicines: Compliance with ICH E6 good clinical practice (GCP) in the United Kingdom」
  https://www.gov.uk/guidance/clinical-trials-for-medicines-compliance-with-ich-e6-good-clinical-practice-gcp-in-the-united-kingdom
• 「Clinical trials for medicines: Diagnostic Radiopharmaceutical Investigation Medicinal Products and Good Manufacturing Practice requirements」
  https://www.gov.uk/government/publications/clinical-trials-for-medicines-diagnostic-radiopharmaceutical-investigation-medicinal-products-and-good-manufacturing-practice-requirements
• 「Clinical trials for medicines: expert advice」
  https://www.gov.uk/guidance/clinical-trials-for-medicines-expert-advice
• 「Common issues identified during clinical trial applications」
  https://www.gov.uk/government/publications/common-issues-identified-during-clinical-trial-applications
• 「Clinical trials for medicines: collection, verification and reporting of safety events」
  https://www.gov.uk/guidance/clinical-trials-for-medicines-collection-verification-and-reporting-of-safety-events
• 「Clinical trials for medicines: ending a clinical trial」
  https://www.gov.uk/guidance/clinical-trials-for-medicines-ending-a-clinical-trial
• 「Formulating responses to GCP inspection findings」
  https://www.gov.uk/government/publications/formulating-responses-to-gcp-inspection-findings
• 「Clinical trials for medicines: guidance on quality and risk proportionality」
  https://www.gov.uk/guidance/clinical-trials-for-medicines-guidance-on-quality-and-risk-proportionality
• 「Clinical trials for medicines: modifying a clinical trial approval」
  https://www.gov.uk/guidance/clinical-trials-for-medicines-modifying-a-clinical-trial-approval
• 「Medicines: clinical trials hub」
  https://www.gov.uk/government/collections/medicines-clinical-trials
• 「Clinical trials for medicines: apply for approval in the UK」
  https://www.gov.uk/guidance/clinical-trials-for-medicines-apply-for-approval-in-the-uk
• 「Clinical trials for medicines: Notification of Serious Breaches of GCP or the trial protocol」
  https://www.gov.uk/government/publications/clinical-trials-for-medicines-notification-of-serious-breaches-of-gcp-or-the-trial-protocol
• 「Clinical trials for medicines: Good clinical practice inspections」
  https://www.gov.uk/guidance/clinical-trials-for-medicines-good-clinical-practice-inspections
• 「Clinical trials for medicines: International Council for Harmonisation (ICH) annotations」
  https://www.gov.uk/government/publications/international-council-for-harmonisation-ich-e6r3-annotations
• 「Clinical trials for medicines: labelling」
  https://www.gov.uk/guidance/clinical-trials-for-medicines-labelling
• 「Clinical trials for medicines: Declaration of Helsinki and Clinical Trial Regulations alignment」
  https://www.gov.uk/government/publications/clinical-trials-for-medicines-declaration-of-helsinki-and-clinical-trial-regulations-alignment
• 「Clinical trials for medicines: notifiable trials」
  https://www.gov.uk/guidance/clinical-trials-for-medicines-notifiable-trials
• 「Clinical trials for medicines: Archiving and retention of clinical trial records」
  https://www.gov.uk/government/publications/clinical-trials-for-medicines-archiving-and-retention-of-clinical-trial-records
• 「Clinical trials for medicines: roles and responsibilities」
  https://www.gov.uk/government/publications/clinical-trials-for-medicines-roles-and-responsibilities
• 「Clinical Trials Regulations enforcement provisions」
  https://www.gov.uk/government/publications/clinical-trials-regulations-enforcement-provisions
• 「Clinical trials for medicines: non-investigational medicinal products」
  https://www.gov.uk/guidance/clinical-trials-for-medicines-non-investigational-medicinal-products
• 「Clinical trials for medicines: good manufacturing practice and radiopharmaceutical investigational medicinal products」
  https://www.gov.uk/guidance/clinical-trials-for-medicines-good-manufacturing-practice-and-radiopharmaceutical-investigational-medicinal-products
• 「International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines」
  https://www.gov.uk/guidance/international-council-for-harmonisation-of-technical-requirements-for-pharmaceuticals-for-human-use-guidelines

【5/7付追記更新】
5/6付のECA/GMP Newsが「UK GMP for IMPs」と題して記事に取り上げています。

BrexitによりEU-GMPの順守義務は無くなったものの、PIC/S加盟もしているということで、PIC/S GMP Annex 13をベースで英国MHRAとして臨床試験に使用する治験薬のラベリングについて詳細に示したというものです。

興味のある方は、下記URLのニュース記事をご参照ください。
https://www.gmp-compliance.org/gmp-news/uk-gmp-for-imps