※追記更新（2020.09.03）
※追記更新（2020.09.04）
9/1付として英国MHRAから「2021年1月1日以降における各規制の変更 」に関する通知が多数発出されています。
Brexitによる現行対応が本年末に期限を迎えることからの変更対応です。
GMPや品質関連だけではありませんが、英国と輸出入の関係にある企業いあっては、何らかの影響が及びますので、ウエブサイトをご確認ください。
l全体のウェブサイト「Latest from the Medicines and Healthcare products Regulatory Agency: Search」
https://www.gov.uk/search/all?organisations%5B%5D=medicines-and-healthcare-products-regulatory-agency&order=updated-newest&parent=medicines-and-healthcare-products-regulatory-agency
［以下は、個別のガイダンス等です］
MHRA post-transition period information
Guidance on the handling of applications for Centrally Authorised Products (CAPs) pending on 1 January 2021
List of approved countries for authorised human medicines from 1 January 2021
Procedures for UK Paediatric Investigation Plan (PIPs) from 1 January 2021
Completed Paediatric Studies - submission, processing and assessment from 1 January 2021
Regulating medical devices from 1 January 2021
Reference Medicinal Products (RMPs) from 1 January 2021
Guidance on pharmacovigilance procedures in the event from 1 January 2021
Renewing Marketing Authorisations for medicines from 1 January 2021
Format and content of applications for agreement or modification of a Paediatric Investigation Plan and requests for waivers or deferrals and concerning the operation of the compliance check from 1 January 2021
Guidance on new provisions for traditional herbal medicinal products and homoeopathic medicinal products from 1 January 2021
Guidance on licensing biosimilars, ATMPs and PMFs from 1 January 2021
Comparator products in Bioequivalence/Therapeutic Equivalence studies from 1 January 2021
Registering to make submissions to the MHRA from 1 January 2021
Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland from 1 January 2021
Webinars: preparing to make submissions to the MHRA from 1 January 2021
Importing investigational medicinal products into Great Britain from approved countries from 1 January 2021
Acting as a Responsible Person (import) from 1 January 2021
How Marketing Authorisation Applications referred under Article 29 will be handled from 1 January 2021
Handling of Active Substance Master Files and Certificates of Suitability from 1 January 2021
Registration of clinical trials for investigational medicinal products and publication of summary results from 1 January 2021
Applying for a Certificate of Pharmaceutical Product from 1 January 2021
Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs) from 1 January 2021
Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) from 1 January 2021, 'grandfathering' and managing lifecycle changes
Guidance on substantial amendments to a clinical trial from 1 January 2021
Registering new packaging information for medicines from 1 January 2021
Importing medicines on an approved country for import list from 1 January 2021
Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice from 1 January 2021
【9/3付追記更新】
9/2付のRAPSが「MHRA posts suite of post-transition guidances」と題して記事に取り上げています。
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.raps.org/news-and-articles/news-articles/2020/9/mhra-posts-suite-of-post-transition-guidances
【9/4付追記更新】
9/3付のRAPSが「MHRA: Post-transition guidance on licensing medicines」と題して関連記事を掲載しています。
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.raps.org/news-and-articles/news-articles/2020/9/mhra-post-transition-guidance-on-licensing-medicin
【9/4付追記更新】
9/3付のGMP Verlagが「MHRA publishes numerous guidelines for post-brexit period」と題して記事に取り上げています。
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-publishing.com/content/en/gmp-news/news-about-gmp-cgmp/d/mhra-publishes-numerous-guidelines-for-post-brexit-period
※追記更新（2020.09.04）
9/1付として英国MHRAから「2021年1月1日以降におけ
Brexitによる現行対応が本年末に期限を迎えることからの変
GMPや品質関連だけではありませんが、
l全体のウェブサイト「Latest from the Medicines and Healthcare products Regulatory Agency: Search」
https://www.gov.uk/search/all?
［以下は、個別のガイダンス等です］
MHRA post-transition period information
Guidance on the handling of applications for Centrally Authorised Products (CAPs) pending on 1 January 2021
List of approved countries for authorised human medicines from 1 January 2021
Procedures for UK Paediatric Investigation Plan (PIPs) from 1 January 2021
Completed Paediatric Studies - submission, processing and assessment from 1 January 2021
Regulating medical devices from 1 January 2021
Reference Medicinal Products (RMPs) from 1 January 2021
Guidance on pharmacovigilance procedures in the event from 1 January 2021
Renewing Marketing Authorisations for medicines from 1 January 2021
Format and content of applications for agreement or modification of a Paediatric Investigation Plan and requests for waivers or deferrals and concerning the operation of the compliance check from 1 January 2021
Guidance on new provisions for traditional herbal medicinal products and homoeopathic medicinal products from 1 January 2021
Guidance on licensing biosimilars, ATMPs and PMFs from 1 January 2021
Comparator products in Bioequivalence/Therapeutic Equivalence studies from 1 January 2021
Registering to make submissions to the MHRA from 1 January 2021
Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland from 1 January 2021
Webinars: preparing to make submissions to the MHRA from 1 January 2021
Importing investigational medicinal products into Great Britain from approved countries from 1 January 2021
Acting as a Responsible Person (import) from 1 January 2021
How Marketing Authorisation Applications referred under Article 29 will be handled from 1 January 2021
Handling of Active Substance Master Files and Certificates of Suitability from 1 January 2021
Registration of clinical trials for investigational medicinal products and publication of summary results from 1 January 2021
Applying for a Certificate of Pharmaceutical Product from 1 January 2021
Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs) from 1 January 2021
Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs) from 1 January 2021, 'grandfathering' and managing lifecycle changes
Guidance on substantial amendments to a clinical trial from 1 January 2021
Registering new packaging information for medicines from 1 January 2021
Importing medicines on an approved country for import list from 1 January 2021
Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice from 1 January 2021
【9/3付追記更新】
9/2付のRAPSが「MHRA posts suite of post-transition guidances」と題して記事に取り上げています。
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.raps.org/news-and-
【9/4付追記更新】
9/3付のRAPSが「MHRA: Post-transition guidance on licensing medicines」と題して関連記事を掲載しています。
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.raps.org/news-and-
【9/4付追記更新】
9/3付のGMP Verlagが「MHRA publishes numerous guidelines for post-brexit period」と題して記事に取り上げています。
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-publishing.
執筆者について
古田土 真一
経歴
GMDPコンサルタント（Pharmaceutical Quality Science Advisor） 1979年より田辺製薬(株)(現田辺三菱製薬)にて合成探索研究、プロセス・工業化研究、CMCプロジェクト開発、治験薬QA、コーポレートQAを歴任。2008年より武州製薬(株)にてQA/QCの管理監督。2009年より中外製薬(株)にて治験薬・医薬品のQA業務・品質システムを改革推進。2013年よりアステラス・アムジェン・バイオファーマ(株)にてCMC・Supply Chain・QAの長として業務構築。2015年より三井倉庫ホールディングス(株)にてヘルスケア製品の事業開発アドバイザーとして業務構築。2015年9月より (国立研究開発法人) 国立精神・神経医療研究センター／トランスレーショナル・メディカルセンター臨床研究支援部アドバイザーとして医薬品開発を、また2022年11月からジェダイトメディスン(株)の品質アドバイザーとして医薬品上市を支援中。
医薬品の開発から上市・保管・流通までを品質の側面から一貫した経験を活かし、GMDPコンサルタントとしてGood Practicesの支援依頼に対応中。
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