EMAからの6/11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URLsのウェブサイトをご参照ください。
●6/11付News Release「International regulators and WHO address need to boost COVID-19 vaccine confidence」
https://www.ema.europa.eu/en/news/international-regulators-who-address-need-boost-covid-19-vaccine-confidence
●6/11付Updated「International Coalition of Medicines Regulatory Authorities (ICMRA)」
https://www.ema.europa.eu/en/partners-networks/international-activities/multilateral-coalitions-initiatives/international-coalition-medicines-regulatory-authorities-icmra
●6/11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
●6/11付News Release「COVID-19 vaccines: update on ongoing evaluation of myocarditis and pericarditis」
https://www.ema.europa.eu/en/news/covid-19-vaccines-update-ongoing-evaluation-myocarditis-pericarditis
●6/11付News Release「Vaxzevria: EMA advises against use in people with history of capillary leak syndrom」
https://www.ema.europa.eu/en/news/vaxzevria-ema-advises-against-use-people-history-capillary-leak-syndrome
●6/11付News Release「Additional manufacturing capacity for Moderna’s COVID-19 vaccine」
https://www.ema.europa.eu/en/news/additional-manufacturing-capacity-modernas-covid-19-vaccine
●6/11付EPAR「COVID-19 Vaccine Moderna」
https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-moderna
●6/11付News Release「COVID-19 Vaccine Janssen: authorities in EU take steps to safeguard vaccine quality」
https://www.ema.europa.eu/en/news/covid-19-vaccine-janssen-authorities-eu-take-steps-safeguard-vaccine-quality
●6/11付Assessment report「Sotrovimab (also known as VIR-7831 and GSK4182136) - COVID19 - Article-5(3) procedure: Assessment report」
https://www.ema.europa.eu/en/documents/referral/sotrovimab-also-known-vir-7831-gsk4182136-covid19-article-53-procedure-assessment-report_en.pdf
●6/11付Updated「Article 5(3) opinions」
https://www.ema.europa.eu/en/human-regulatory/post-authorisation/referral-procedures/article-53-opinions
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