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イギリス(イングランド、ウェールズ、スコットランド、北アイルランド)からの薬局性能力手順に関するMHRAガイダンスMHRA Guidance on Pharmacovigilance procedures from for Great Britain (England, Wales, Scotland and Northern Ireland)
MHRAより医薬品安全性監視手順に関するガイダンスが発出されました。Last updated:29 January 2021,
2021年1月1日より、英国国内で承認されている医薬品について、製造販売承認取得者 (MAH) は、MHRAのPharmacovigilance Guidance要件に従って医薬品安全性監視データ全般をMHRAに提出する必要があります(対象範囲は以下のContents参照)。北アイルランドは、従来通りEMA(EU)の規定に従って対応する部分と、個別有害事象ICSR報告に関しては、英国全体(北アイルランド含む)とする規定が含まれていますのでご注意ください(ただし続報報告などの特例規定あり)。また、RMPs, PSURsなどのリスクマネージメント・集積報告は、EMA報告との継続性考慮が必要な要件がありますので合わせてご覧ください。
詳細は、本項末尾の [Reference URL] からオリジナルのガイダンスをご参照ください。
2. Actions for submitting and receiving ICSRs
We will require submission of all UK (including Northern Ireland) ICSRs (serious and non-serious) and serious ICSRs from other countries via the new MHRA Gateway or/ICSR Submissions portal which have been developed.
1. General Approach to the operation of pharmacovigilance
The MHRA retains responsibility for Pharmacovigilance across the UK.
There are some different requirements for products placed on the market in the UK with respect to Great Britain and Northern Ireland. Great Britain is England, Wales and Scotland. For products authorised for sale or supply in Northern Ireland EU pharmacovigilance requirements will continue to apply in addition to UK requirements as indicated below:
For medicines which are authorised nationally in the UK, you as a Marketing Authorisation Holder (MAH), will be required to submit pharmacovigilance data to the MHRA, according to UK requirements, including:
• UK and non-UK Individual Case Safety Reports (ICSRs)
• Periodic Safety Update Reports (PSURs)
• Risk Management Plans (RMPs)
• Post-Authorisation Safety Studies (PASS) protocols and final study reports
Guidance on pharmacovigilance procedures
This guidance summarises our approach to pharmacovigilance
From: Medicines and Healthcare products Regulatory Agency
Published:31 December 2020
Last updated:29 January 2021,
Contents
1.General Approach to the operation of pharmacovigilance
2.Actions for submitting and receiving ICSRs
3.Signal detection
4.Risk Management Plans (RMPs)
5.Periodic Safety Update Reports (PSURs)
6.Post Authorisation Safety Studies (PASS)
7.Safety Referrals
8.Major Safety Reviews
9.Post-authorisation Measures (PAMs)
10.Implementation of outcomes of referrals and procedures concerning PSURs, PASS, signal assessments and PAMs
11.Requirements for MAs granted via the Unfettered Access route
12. Contact
[Reference URL]
[pat of Brexit : Home > Vigilance > safety alerts and guidance]
https://www.gov.uk/government/publications/guidance-on-pharmacovigilance-procedures
[Vigilance, safety alerts and guidance Guidance on pharmacovigilance procedures]
Guidance Guidance on pharmacovigilance procedures Updated 29 January 2021
https://www.gov.uk/government/publications/guidance-on-pharmacovigilance-procedures/guidance-on-pharmacovigilance-procedures
[Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF)]
https://www.gov.uk/guidance/guidance-on-qualified-person-responsible-for-pharmacovigilance-qppv-including-pharmacovigilance-system-master-files-psmf
[A list of reports received via the EMA from 28 December to 31 December ] –> “MHRA_ICSR_Reconciliation_Sheet.xlsx”
[Guidance on submitting clinical trial safety reports 31 December 2020]
https://www.gov.uk/guidance/guidance-on-submitting-clinical-trial-safety-reports
以下は、「Newsletter Vol.1 No.8 : 「英国合意なきEU離脱: NO DEAL BREXIT」 のPVへのインパクトは?」からの転載です(昨年のBrexit 参考情報です)。
1. 有害事象個別症例報告は、EMAとは別にMHRA(英国医薬品・医療製品規制庁)にも報告が必要か? まずは、以下の3点につき調査してみました(Page-4 Referenceも参照ください)。
1) 10月31日(EU離脱期限:4月10日のEU首脳会合で定められた新たな離脱期限)以降、2019年11月 1日(金)からは即時に、EMA報告とは別にMHRAへの報告が義務付けられるのか?
2) もし、上記報告義務が開始されるとしても「猶予期間」は設定されないのか?
3) 電子報告のための、MHRA EDI接続テストが完了しない場合の Web報告のような代替手段はあるのか?
2. 次ページに直接 MHRAへメールで問合せた結果の Q&Aを示します。
QuestionsとAnswersが完全に噛み合っていない感もありますが、現在英国・EU間での交渉がまだ継続していますので、現在のところこの回答を持って状況判断をせざるを得ません。以下サマリーしますと。。。(貴社のアクションにあたっては、適時 MHRA Web Siteの最新発出のご確認をお願いします)
- MHRAは、「合意なきEU離脱」となった場合に備えて、すでにWeb Portalへのアップロード報告サイトを用意しているので、この報告手段を準備することが可能。(猶予期間には言及せず)。
- EDI電子報告の接続も可能であるので、接続テスト申請・実施後UAT(MDN確認可能)を行うことを推奨
- Web Portal/ EDIのいずれの報告手段を取るにしても、詳細な手順を公開しているので、それを参考にして各社での事前の社内トレーニングを行う必要がある。
MHRA Q&A Mail (12-Oct-2019) from MHRA
Dear Hiro Atsumaru,
Thank you for your email.
With regards to your question stating below.
1)Is it mandatory for the UK Government (MHRA) to initiate electronic reporting from 1st Nov 2019 to UK authorities(MHRA) immediately if there is a no-deal Brexit at the end of Oct 2019?
The MHRA Submissions portal was built and ready to use for the original EU exit date of 29 March 2019. Prior to this date the MHRA held a number of deep dives and webinars to keep industry engaged with the build and delivery of 11 EU replacement systems.
Since February 2019, industry have had the ability to register for these systems with guidance available on the MHRA website.
Webinars have also been uploaded to our website which offer detailed step by step instructions on how to use each replacement system. These are available now and should be used for internal training with your members regulatory affairs departments.
2)If we do not complete the MHRA Connectivity Test of the electronic report by the end of October 2019, how long will we be given postpone?
Once registration is completed, you are encouraged to perform a connectivity test in UAT. You will be able to confirm success via MDN receipt.
3)Are methods and measures provided for adverse event cases other than electronic reporting via EDI? i.e Web site upload ICSRs
With regards to further information on this question, please send this to the following team – E2B.support@mhra.gov.uk
I hope this has answered your questions.
Customer Service Office
Communications Division
Medicines and Healthcare Regulatory Agency
10 South Colonnade, Canary Wharf,
London E14 4PU
Prepare for Brexit: Click here to find out how to Register to make submissions to the MHRA after 31 October if there is a no-deal Brexit.
submissions@mhra.gov.uk
Think in green! Not every email needs to be printed
3. EMA側の発出とQ&Aに関しては、Page-4/ 5. Reference 11), 12) and 13)をご参照ください。
4. Gateway Management Demo Screen
https://mhra-transfer.sharefile.com/share/view/se3fd421a05a4b72b


5. Reference
Register to make submissions to the MHRA if there is a no-deal Brexit
Submissions related to human medicines would need to be submitted directly to the MHRA.
1)https://www.gov.uk/guidance/making-submissions-to-the-mhra-in-a-no-deal-scenario#gaining-access-to-mhra-submissions
2)https://www.gov.uk/guidance/making-submissions-to-the-mhra-in-a-no-deal-scenario
3)https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/794639/BCP_ICSR_Submissions.pdf
4)https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/830001/210819_Gaining_Access_to_MHRA_Submissions.pdf
6)https://mhrabpm.appiancloud.com/suite/plugins/servlet/registration
7)https://mhra-transfer.sharefile.com/share/view/se3fd421a05a4b72b
8)https://www.jetro.go.jp/ext_images/_Reports/01/63e5b8fb0ea6b7c8/20180024.pdf
9)https://www.mizuho-ri.co.jp/publication/research/pdf/insight/eu190905.pdf