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英国合意なきEU離脱: No Deal Brexit PVインパクトWhat is the impact of “EU Withdrawal without UK Agreement: NO DEAL BREXIT” on PV?

Hiro Pharma Consulting Newsletter 1巻 8号 「英国合意なきEU離脱: NO DEAL BREXIT」 のPVへのインパクトは?

https://www.gov.uk/guidance/making-submissions-to-the-mhra-in-a-no-deal-scenario#gaining-access-to-mhra-submissions
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.

GLPではすでに厚労省が一部調整済だが GVPでは?
「英国当局の確認を受けた GLP 基準に適合した試験施設により作成された 試験成績の取扱いについて(お知らせ)」 [5. Reference 10) page-4]

 

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

  1. 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)。
  2. 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
  3. 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

5)https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/783370/URG_-_Managing_users_on_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

10)https://www.meti.go.jp/policy/chemical_management/kasinhou/information/GLPBrexitoshirase.pdf?fbclid=IwAR2lbWh_sKJeq0tQrJGsDnIjJIO6-iRmW9dNDjdF5HAt-m9vBmWD1m_D8Xg

11)https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/practical-guidance-procedures-related-brexit-medicinal-products-human-veterinary-use-within_en.pdf

12)https://www.ema.europa.eu/en/news/questions-answers-eu-actions-prevent-medicine-shortages-due-brexit

13)https://www.ema.europa.eu/en/documents/other/european-authorities-working-avoid-shortages-medicines-due-brexit-questions-answers_en.pdf