2020/11/04

Yakuji Nippo

Scientific Advice for COVID-19 Vaccines Development Starts – Free Advice on Online and others.


株式会社薬事日報社から許諾を受けて、株式会社シーエムプラスが英語に翻訳しております。
オリジナルの正式言語は日本語であり、内容および解釈については日本語が優先されます。
With permission from Yakuji Nippo, Limited, CM Plus Corporation translated into English.
The original article is authored in Japanese, and the Japanese shall prevail in meaning in terms of content and interpretation.

【Pharmaceuticals and Medical Devices Agency】
Scientific Advice for COVID-19 Vaccines Development  Starts – Free Advice on Online and others

October 9th, 2020

Pharmaceuticals and Medical Devices Agency (PMDA) started "Scientific Advice for COVID-19 Vaccines Development" on the 1st. For pharmaceutical companies and universities that are considering the development of vaccines for novel coronavirus infections, the review department of vaccines  will provide free advice on necessary studies and development of clinical trial protocols through the face-to-face meeting or on online.

In the "Principles on Evaluation of COVID-19 Vaccines"  published by the PMDA in September, it was recommended that the scientific advice should be provided as early as possible, since a certain period is required to conduct domestic clinical studies and to confirm whether the vaccines comply with the Cartagena Act that indicates regulatory actions for use of genetically modified organism. The free scientific advice will be conducted based on the same idea.

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