Case Study 12: Regulatory Strategy and MAH Services in Japan

Company Situation

The Client is a European manufacturer of API and wanted to register the DMF of one of its APIs in Japan before selling its API to a drug manufacturer in Japan. Client was seeking a partner who could support him in Japan by preparing and submitting the API DMF and communicating regularly with the drug product manufacturer in Japan that will be using the API.

GRP Solution

In Japan, GRP is licensed as category 1 MAH for medical devices and worked with client as a Strategic Partner allowing him to expand into Japanese market with minimal risk. GRP followed a multi-phase approach to enable Client to register and commercialize its devices in Japan in record time:

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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.