souseikai global clinical research center

FIVE REASONS to Think About Clinical Trials in JAPAN

Why TARGET the Japanese Market?

ONE

Japan is the SECOND LARGEST single-nation PHARMECEUTICAL MARKET

TWO

The Japanese pharmaceutical market is relatively UNTAPPED by FOREIGN pharmaceutical/biotech COMPANIES

Three

Home to the LARGEST Elderly Population IN THE WORLD
*In developed countries such as Japan and the United States, 34 percent of prescription medication and 30 percent of OTC medication use are by the elderly population. The Japanese elderly population tops all others, those aged 65 or older accounting for 26.7% of its population of 127.11 million people, and continues to grow.

FOUR

The culture’s MEDICINE-FRIENDLY MINDSET and FULLY DEVELOPED national healthcare coverage

FIVE

A FAST and AMBITIOUS Regulatory System
*The Clinical Trial Notification (CTN) scheme, different from the IND process, allows for first submission new chemical entities to start clinical trials 30 days after the CTN has been submitted to the PMDA regulatory authority.

*Orphan Drug Development
http://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/orphan_drug.html

Need FIVE more?
Why CONDUCT clinical trials in Japan:

SIX

CLINICAL DEVELOPMENT Infrastructure and Logistics’ QUALITY, SAFETY, and RELIABILITY levels are HIGH, as well as GLOBALLY COMPETITIVE

SEVEN

TEASILY ACCESS the Japanese Market

EIGHT

EASILY OBTAIN needed Asian data for trials IN YOUR OWN REGION

NINE

PROCURE Japanese/ASIAN data for BRIDGING and MULTI-REGIONAL TRIALS

TEN

Target OTHER ASIAN Markets; SIMULTANEOUSLY conduct Japanese and Caucasian Trials