Keyword Analysis & Research: pmda agency


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What is PMDA and what does it do?

Here begins the text. PMDA (Pharmaceuticals and Medical Devices Agency) is Japanese regulatory agency, working together with Ministry of Health, Labour and Welfare. Our obligation is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices.

What is the MHLW and the PMDA?

In conjunction with the MHLW, the Pharmaceutical and Medical Device Agency (PMDA) is an independent agency that is responsible for reviewing drug and medical device applications. The PMDA works with the MHLW to assess new product safety, develop comprehensive regulations, and monitor post-market safety.

What does the PMDA do when a new risk is identified?

When a new risk is identified, the Pharmaceuticals and Medical Devices Agency (PMDA) thoroughly investigates the risk and discusses a necessity of revision of PRECAUSIONS with expert advisors so that the PMDA can recommend an additional safety measure to the Ministry of Health, Labour and Welfare (MHLW).

What is the pharmaceuticals and Medical Devices Agency?

The Pharmaceuticals and Medical Devices Agency (PMDA) is the government organization in Japan in charge of reviewing drugs and medical devices, overseeing post-market safety, and providing relief for adverse health effects.

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