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

2020年10月09日 (金)

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.

For pharmaceutical companies, universities, and academic institutions that are considering vaccine development, aiming to start clinical studies early, the review department of vaccines will advise on necessary studies/development of clinical trial protocols, and development program.

If demanding the advice, it is required that an application form is submitted by e-mail to the review management division of the review management department after entering necessary items on the form, including questions, whether there is a consultation about procedures for the Cartagena Act or not, and preference for face-to-face or online.

The consultation time is within one hour per session, and if the content is simple, the answer may be provided by telephone or e-mail.

For consultation about specific results of non-clinical studies, specific results of and clinical studies, use of existing face-to-face consultation is recommended., Aand also, for the vaccine to be consulted, the face-to-face scientific advice after using the existing consultation is treated as priority consultation (face-to-face) and accepted as needed.


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