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Japan's PMDA: Reporting ADR & Defects during Clinical Trials using e-Application Data System

Recently Japan's the Ministry of Health, Welfare and Labour (MHLW) - Pharmaceuticals and Medical Devices Agency issued guidance System for reporting side effects and defects during clinical trials.

From (yesterday) April 1, 2023, it is required to submit reports of adverse drug reactions and defects during clinical trials online using the electronic application data system.

Earlier reports of clinical trial adverse reactions/malfunctions and the latest clinical trial safety reports are accepted by e-mail only when it is difficult to submit them in paper form.

The Pharmaceuticals and Medical Devices Law requires clinical trial sponsors (pharmaceutical companies, etc.) and physicians or dentists (those who conduct clinical trials themselves) to report adverse reactions, problems, etc. The Minister of Health, Labor and Welfare must be kept informed during clinical trials.

For example. The sponsor or the person conducting the clinical trial must report the defect to PMDA within seven days or fifteen days (or 30 days in the case of only a defect) after it becomes known.

A clinical trial notification must be submitted between the date of notification and the date of approval or submission of the development discontinuation notification. Clinical trial notifications are not required if they are submitted between the start date in the protocol and the date of approval or notification of development discontinuation.

The PMDA will organize the report's information, etc., and report the status to the Ministry of Health, Labor, and Welfare.

Click this LINK to check in detail about the requirements to submit online notifications such as clinical trial notifications using the electronic application data system.


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