For the investigational products (IPs) showing promise for your initially targeted market, one of the next steps for your IPs’ worldwide introduction can be started in Japan.
Since the ICH E5 guideline ‘Ethnic Factors in the Acceptability of Foreign Clinical Data’ was published in 1998, SOUSEIKAI has been helping global pharmaceutical companies to facilitate their drug and biologic registrations in Japan/Asia as well as the world, without causing them billions of sales loss that might occur with any regional NDA approval gap.
The published data also show that by using the bridging strategy, the time to NDA in Japan could be shortened to 32 months compared to 56 months with full development repeated in Japan. (Uyama Y et al, Clin Pharmacol Ther, 78: 102-113, 2005)
In Japan as one of the ICH countries, drug approval based on the bridging strategy has rapidly increased since the ICH E5 guideline.
Although many global pharmaceutical companies have acknowledged the importance of Asia/Japan market, non-Asian countries tended to be chosen for the Asian/ Japanese studies due to the lack of information about the current status of Japanese clinical trial process and capabilities.
Why is SOUSEIKAI the best location to conduct Ethnobridging studies;
・Quick study initiation with Japanese CTN scheme;
Starting clinical trials in Japan does not require IND submission and its approval.
With rather simple Japanese 30 days Clinical Trial Notification(CTN) scheme, you can strategically plan the next necessary steps such as IRB preparation, study contract review, and subject recruitment, etc during this period so that your study can be intiated as soon as the CTN is opened.
・Cost-Effective Studies in JAPAN;
Clinical trial costs in Japan used to be relatively high in the past however, it has come to be recognized that the costs, especially for early phase studies are now even lower than those of western countries. In addition, we screen about 25,000 healthy Japanese for about 280 studies each year. Our long-standing relationship with these volunteers will make the recruitment for Japanese subjects both quick and low-cost.
The operational cost as well as the recruitment cost can be minimized compared to Japanese studies conducted outside Japan.
・Easy Access to Asian/Caucasian Volunteers;
Over 1,000 healthy Caucasian, Korean, Taiwanese, and Chinese Male and Female volunteers are currently registered in our volunteer database as well as 30,000 Japanese volunteers.
To date, we have enrolled more than 1,200 non-Japanese volunteers who have lived outside their home countries for less than 5 years.
・Studies conducted with ICH-GCP and J-GCP compliance
Many of the phase 1 protocols have included Japanese/Asian study arms in the recent years.
This Asian integrating strategy makes it possible to detect ethnic variations early on, in comparison to the initially targeted population -- such as differences in pharmacokinetics, safety, tolerability, and pharmacodynamic profiles.
Having this information earlier at hand is significantly advantageous for the pharmaceutical companies aiming at the global market.
Such multi-ethnicity data will not only support you to plan the future studies accordingly, but also, lead to the Global Studies with all the data necessary to include Japan/Asian sites by the time you reach the Phase 3 studies.
At SOUSEIKAI, we have enrolled over 1,200 Caucasian/Asian subjects for key endpoint studies (SAD, MAD, Food Effect, Ethnicity Comparision, PD).
These studies include the following;
Please feel free to contact us about your studies and ambitions, and how we can help support your drug development in Japan and Globally.