Case Study 16: Support for Change of In-Country Caretaker (ICC) in Japan for a European API company Client Situation

Company Situation

Client was new to Japan market and needed end to end support right from strategy, product registration, marketing authorization holder in country, importation and custom clearance, pharmacovigilance, distributor identification and post approval maintenance of product license in Japan.

GRP Solution

GRP was right partner for client due to its local presence in Japan and tremendous experience of its regulatory experts in registering devices ensuring safety and compliance of device as per Japanese regulations.

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Aerial view of Tokyo cityscape with Fuji mountain in Japan, Tokyo

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.