souseikai global clinical research center

Why JAPAN?

Japan has been revisited as an ideal location to conduct early clinical trials. Here are some reasons why Japan is now so popular among global pharmaceutical and biotech companies.

Matured Pharmaceutical Market

Superior Clinical Trial System

SPEED

Japan’s NDA review time is the fastest in the world.

Japan Australia US EU
Regulatory Authority PMDA TGA FDA EMA
IRB/EC approval 1 day* 1-3 months 2-3 months 2 months
CTN/IND/CTA scheme CTN:
30 days
*14 days for subsequent submissions
CTN:
7-14 days
IND:
30 days
CTA:
60-106 days
Median NDA/MAA Review Time 357 days 364 days 365 days 441 days

*SOUSEIKAI IRB Review/Approval Time

QUALITY

Japan’s clinical trial quality has been highly respected worldwide.

As an original ICH country, we comply with ICH-GCP and Japanese GCP.

At SOUSEIKAI alone, we have had 60 GCP on-site inspections with all the results being No Action Indicated (NAI) from the US FDA, Korea MFDS, and Japanese PMDA.

COST

Japan’s clinical trial costs are now very competitive when compared with other countries.

In particular, early clinical trial costs have been confirmed to be the lowest in the world by the industry since the mid 2010s. For foreign companies, VAT (10%) will be waived.

REGULATIONS

Japan is one of the three ICH founding members, and has greatly contributed to the world’s drug development. Listed below are examples of the Japanese clinical trial regulations which aim to facilitate drug development in Japan and the information about PMDA’s Consultation Services which we recommend to our global sponsors.

FAVORABLE R&D Environment

Established Clinical trial infrastructure

The pharmaceutical industry has been a major industry in Japan for a long time. Many great talents have emerged and engaged in this industry, and the accumulated knowledge and impact on drug development to date has been enormous. Historically, healthy volunteer studies have been led by specialized phase 1 sites in Japan. Thanks to the continued efforts made by the Japanese government and private sectors for the last half-century, Japan’s clinical trial infrastructure continues to be on par or outpace other global competitors/infrastructures.

A Driving force for market growth

Japan is a super-aged society and has the highest “aging rate” in the world (28.7%), defined as the proportion of a society’s population that is comprised of persons age 65 or older. 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.