Case Study 30 : Registration of API DMF and In-Country Care Taker 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

GRP with its teams based locally in Tokyo, was a partner of choice for Client combined with GRP’s experience in successfully registering 20+ DMFs in Japan. GRP helped the Client in planning their DMF registration in Japan based on Client’s commercial plan and to obtain the DMF approval as scheduled.

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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.