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Japan

Locally based project management capabilities and regulatory expertise

Japan continues to be one of the largest pharmaceutical markets in the world.

With an aging population of nearly 127 million, the Japanese market for prescription and non-prescription pharmaceuticals in 2020 was $107 billion, according to the (MHLW)'s Annual Pharmaceutical Production Statistics.

  • 27

    Years in Japan

  • 950+

    Staff based in Japan

  • 125+

    Full-service studies in the last five years

Choosing the right partner

In recent years, the Japanese drug and medical device approval authority, the Pharmaceuticals and Medical Devices Agency (PMDA), has modified its approval process, making it easier to bring new drugs to the market in Japan.  Nevertheless, there are economic, cultural and regulatory challenges that make it critical to choose a CRO partner that is well-established in Japan, with the expertise and experience to provide guidance and solutions throughout the drug development process.

Strong heritage and growing

ICON is a global CRO, with a presence in Japan since 1996. We provide full geographic reach, to allow for the most efficient site monitoring. With over 950 staff in Tokyo, Osaka, and home-based, we deliver global and local capabilities to pharmaceutical, biotechnology, medical device and government and public health organisations. ()

Clinical and regulatory expertise

Our experts have extensive experience of supporting global and local pharmaceutical, biotechnology and medical device organisations in their clinical development programs. With deep therapeutic experience particularly in oncology, CNS and infectious diseases; excellent relationships with regulatory bodies such as the PMDA and a well-developed network with investigative sites, we break down the barriers of reaching your milestones.

Full range of services 

ÃÛÌÒ´«Ã½ can provide you with a full range of clinical development services to support global, pan-Asia Pacific, and local trials in Japan. With locally based project management capabilities and regulatory expertise, you will get the insight, innovation and performance that will make a difference to cycle times and quality of data.