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
- The 2nd largest pharmaceutical market in the world
- Seventeen Japanese pharmaceutical companies were ranked in the World's Top 100 Pharma Companies by Revenue in 2018 (https://novasecta.com/wp-content/uploads/2019/04/The-Novasecta-Global-100-2019.pdf) .
- Over 350 pharmaceutical companies in Japan are active in partnering with global pharma and biotech companies.
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.
-
Strategy of SAKIGAKE
https://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/dl/140729-01-01.pdf -
Overview of the Orphan Drug/Medical Device Designation System
https://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/orphan_drug.html -
Regulatory Framework of Regenerative Medicines and Product Review in Japan
https://www.pmda.go.jp/files/000226121.pdf -
PMDA's Consultation Service
https://www.pmda.go.jp/files/000219654.pdf
FAVORABLE R&D Environment
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- The 5th highest International Property Rights Index (IPRI) score in the world in 2020. (https://atr-ipri2017.s3.amazonaws.com/uploads/IPRI+2020+Full+Report.pdf) .
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 窶彗ging rate窶 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.
