Japan is the second largest market for pharmaceuticals, representing ten percent of the world’s pharmaceutical market.

George Clinical In Japan

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.

Why is Japan attractive for sponsors to conduct clinical trials?

  • Pharmaceutical market: The third-largest market in a single country supported by aggressive new drug development and Universal Health Insurance.
  • Drug development environment
    • Well-established clinical development knowledge and environment including clinical investigational sites with well-trained site staff, SMO and regulatory processes. Those sites include university hospitals, institutional hospitals, public and private city hospitals and clinics as well which could provide timely study start-up and patient enrolment with highly eligible subjects in most therapeutic areas.
    • High quality of clinical data with a low drop-out rate in general.
    • The globalization of drug development has been well developed and more than 50% of clinical studies in Japan are Multi-Regional Clinical Trials (MRCT).
    • SAKIGAKE NDA process, a highly expedited evaluation process, is applicable for innovative drug candidates which will be launched first in Japan.
    • New chemical entities are being increased, particularly biotechnology products that are remarkable.
  • Drug research environment: For early-stage clinical development, there are many key researchers and key opinion leaders who could conduct early-stage clinical research such as exploratory clinical study, clinical pharmacology study, or proof of concept study, which could provide the scientific rationale to proceed with further steps of clinical development toward approval and launch.
  • Characteristics and culture: In general, the Japanese are well educated and keen to follow study rules and guidelines which is typically one of the key factors to obtaining a successful result of a clinical study.

Why is the EPSI and George Clinical alliance the CRO of choice for our sponsors in Japan?

  1. Strength of EPS Group in Japan
    • Well recognized as the TOP CRO partnership and site management organizations (SMO) in Japan through a more than 30-year history in Japan by stakeholders, sponsor companies, investigational sites and regulatory bodies.
    • No coverage limitation of therapeutic areas, stage of a clinical study, modality of project or purpose of a clinical study.
    • EPS Group companies cover all service needs, from first-in-man through to marketed products with a one-stop solution including CRO, SMO and CSO. The SMO covers more than 6,600 sites including those from key hospitals to clinics which could accelerate clinical studies sufficiently.
    • Well-trained and experienced staff who could lead and manage clinical study well as well as communicate with investigators and site staff effectively in a timely fashion.



Population 127 million
Official Language Japanese
Hospital Records Language Japanese
In-country services Regulatory consultancy
Project Management
Clinical operations

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