Company Situation
The Client is a is a Japanese CRO that is conducting a phase III clinical study in Japan for a Software medical device ( Class III). The requested pharmacovigilance services during the conduct of the clinical study in Japan.
GRP Solution
GRP team in Japan has significant experience in providing pharmacovigilance services in Japan according to PMDA requirements. The safety team in Japan provided the following services:
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Japan's PMDA
In Japan, The Pharmaceuticals and Medical Devices Agency (PMDA) is the government organization in charge of reviewing drugs and medical devices, overseeing post-market safety, and providing relief for adverse health effects. The PMDA operates under the Ministry of Health, Labor, and Welfare (MHLW) .These two government organization both handle a wide range of activities, from approval reviews to post-market surveillance.