Case Study 13 : New Drug Registration in USA, China and Japan

Company Situation

Client was in process of developing new drug for 2nd line of treatment of biliary tract cancer. They had novel drug designation in US and in China they were entering phase 3 stage of clinical trial and whereas in Japan the trial was ongoing. Client wanted to start the registration process in China and once approved in China they wanted to get registered in US and Japan in parallel. They had a timeline which needed to be adhered to.

GRP Solution

GRP was selected as the right partner for client due to its local presence and tremendous experience of its experts in registering devices for oncology per regulations of respective countries. GRP gave a strategic approach for handling the activities within said timelines and managed the end to end requirement. GRP’s expertise in Chinese and Japanese language enabled seamless interaction with different stakeholders through the product registration process in USA . GRP did a thorough planning of each steps considering the timelines the client was targeting to launch the product. GRP provided comprehensive strategic inputs to Client to enable its successful registration in USA using following process:

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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.