Japan

Since 2007, Japan has released formal guidelines to global clinical trial participation which has encouraged the growth of global clinical trials

George Clinical in Japan

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Since 2007, Japan has released formal guidelines to global clinical trial participation which has encouraged the growth of global clinical trials.

The number of global clinical trials in Japan has grown from 1 to 23 as of 31st December 2014. Clarity around the regulatory framework in Japan has also improved significantly. In addition to the number of 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, Labor 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. As a result of this, it is expected that the IND and NDA process will be simplified in the near future.

Despite the improving environment for global clinical trials in Japan, the relative experience of Japanese investigators and sites conducting international research is still limited. It is therefore critical to work with a local Japanese partner when conducting clinical research in Japan.

Recognising the need for an established and experienced local partner, George Clinical has entered into an agreement with Mediscience Planning Inc. (MPI). MPI has been providing quality services to the Japanese pharmaceutical industry since 1982, providing a full range of clinical trial management services. MPI will provide dedicated local project management and monitoring personnel for George Clinical projects; these teams will be integrated with George Clinical’s central services including project management, quality oversight, medical, safety and data services. MPI will also provide local regulatory services to support the clinical trial in Japan.

What are the benefits of conducting clinical trials in Japan?

  • Medical business is very sophisticated and comparable to Western standards.
  • Japan is the third most efficient producer of new drugs only following behind the US and the UK
  • East Asian data can be accepted as part of the registration data for Japan, which means that possible inclusion of countries such as South Korea, China and Taiwan in the trials is an important factor when considering a drug or device registration in Japan’s lucrative healthcare market

What are the prevalent diseases in Japan?

  1. Lower respiratory infections
  2. Stroke
  3. Ischaemic heart disease
  4. Cancers
  5. Kidney Diseases

Details

In-country Services: Project Management
Clinical operations
Population: 127 million
Official Language: Japanese
Hospital Records Language: Japanese

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