※追記更新（2021.03.29）
EMAからの3/24付でのCOVID-19関連情報です。
ただ、GMP Platform読者に関係しそうなものだけを取り上げていますことをご容赦ください。
また、必要に応じては、ECからの通知等も含めておりますことも、合せてご容赦ください。
関係者および興味のある方は、下記URLのウェブサイトをご参照ください。
l3/24付Updated「COVID-19 Vaccine AstraZeneca: Risk of thrombocytopenia and coagulation disorders」～AZ社ワクチンの血栓に関する最新情報です。
https://www.ema.europa.eu/en/medicines/dhpc/covid-19-vaccine-astrazeneca-risk-thrombocytopenia-coagulation-disorders
l3/24付Updated「COVID-19: latest updates」
https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/covid-19-latest-updates
l3/24付Updated「REGN-COV2 antibody combination (casirivimab / imdevimab) - COVID19 - Article-5(3) procedure: Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring」
https://www.ema.europa.eu/en/documents/referral/regn-cov2-antibody-combination-casirivimab/imdevimab-covid19-article-53-procedure-conditions-use-conditions-distribution-patients-targeted_en.pdf
l3/24付New「Eli Lilly and Company Limited antibody combination (bamlanivimab / etesevimab - COVID19 - Article-5(3) procedure: Assessment report」
https://www.ema.europa.eu/en/documents/referral/eli-lilly-company-limited-antibody-combination-bamlanivimab/etesevimab-covid19-article-53-procedure-assessment-report_en.pdf
l3/24付EC「Coronavirus: new procedure to facilitate and speed up approval of adapted vaccines against COVID-19 variants」
https://ec.europa.eu/commission/presscorner/detail/en/ip_21_1088
［3/29付追記更新：上記関連ニュース記事］
l3/29付FDANews「EU Considers Giving EMA Fast-Track Authority to Adapt COVID-19 Vaccines」
https://www.fdanews.com/articles/202062-eu-considers-giving-ema-fast-track-authority-to-adapt-covid-19-vaccines
l3/24付EC「Commission delegated regulation on the examination of variations to the terms of marketing authorisation for medicinal products for human use and veterinary medicinal products」
https://ec.europa.eu/info/files/commission-delegated-regulation-examination-variations-terms-marketing-authorisation-medicinal-products-human-use-and-veterinary-medicinal-products_en
［上記関連ニュース記事］
l3/24付RAPS「EC advances amendment to speed adapted COVID vaccines」
https://www.raps.org/news-and-articles/news-articles/2021/3/ec-advances-amendment-to-allow-adapted-covid-vacci
EMAからの3/24付でのCOVID-19関連情報です。
ただ、GMP Platform読者に関係しそうなものだけを取り上げています
また、必要に応じては、ECからの通知等も含めておりますことも
関係者および興味のある方は、下記URLのウェブサイトをご参照
l3/24付Updated「COVID-19 Vaccine AstraZeneca: Risk of thrombocytopenia and coagulation disorders」～AZ社ワクチンの血栓に関する最新情報で
https://www.ema.europa.eu/en/
l3/24付Updated「COVID-19: latest updates」
https://www.ema.europa.eu/en/
l3/24付Updated「REGN-COV2 antibody combination (casirivimab / imdevimab) - COVID19 - Article-5(3) procedure: Conditions of use, conditions for distribution and patients targeted and conditions for safety monitoring」
https://www.ema.europa.eu/en/
l3/24付New「Eli Lilly and Company Limited antibody combination (bamlanivimab / etesevimab - COVID19 - Article-5(3) procedure: Assessment report」
https://www.ema.europa.eu/en/
l3/24付EC「Coronavirus: new procedure to facilitate and speed up approval of adapted vaccines against COVID-19 variants」
https://ec.europa.eu/
［3/29付追記更新：上記関連ニュース記事］
l3/29付FDANews「EU Considers Giving EMA Fast-Track Authority to Adapt COVID-19 Vaccines」
https://www.fdanews.com/
l3/24付EC「Commission delegated regulation on the examination of variations to the terms of marketing authorisation for medicinal products for human use and veterinary medicinal products」
https://ec.europa.eu/info/
［上記関連ニュース記事］
l3/24付RAPS「EC advances amendment to speed adapted COVID vaccines」
https://www.raps.org/news-and-
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