Japan is the second largest market for pharmaceuticals, representing ten percent of the world’s pharmaceutical market.
Japan remains the largest market for clinical trials in the Asia-Pacific region and is an important country for conduct of both global and local studies for product regsitration.
The regulatory system has undergone significant changes in recent years with a greater acceptance of overseas data and clarity around the regulatory framework in Japan has also improved significantly. In addition to the new guidelines that have been released by Japan’s regulatory body for medicines – the Pharmaceutical and Medical Devices Agency (PMDA) – addressing global clinical trials, Japan’s Ministry of Health, Labour and Welfare – which oversees the PMDA – also released the a new national strategic framework that hopes to expand access to innovative medical products in Japan. These initiatives have reduced trial start up times and encouraged companies to include Japan as part of global and APAC development programmes.
Despite the improving environment for global clinical trials in Japan, there are significant differences for the conduct of trials thus it is important to work with a CRO who has a strong local Japanese partner when conducting clinical research in Japan.
George Clinical will establish its own entity for conduct of Global and APAC trials which include Japan and work with our experienced partner for Japan only clinical trials.
|Hospital Records Language||Japanese|
|In-country services||Regulatory consultancy