Having Japanese data is key to successful entry into the Japanese market. Since the ICH-E5 was implemented in 1998, the Japanese PMDA has greatly expanded the regulatory pathway which enables foreign sponsors to leverage their existing foreign clinical data for registration in Japan. Instead of fully repeating costly and time-consuming clinical trials with Japanese subjects, foreign sponsors can now get into the lucrative Japanese market with essential Japanese data.
The following are the reasons why you should consider conducting Japanese studies in Japan:
Advantages with Global Clinical
According to the PMDA’s guidance on the “Basic Principles for Conducting Phase 1 Trials in the Japanese Population Prior to Global Clinical Trials”, when foreign sponsors plan to conduct global clinical trials that include Japan, a Japanese Phase 1 study should be considered before starting the global clinical trial. Guidance also states that even if a Japanese phase 1 study is not conducted, a Japanese clinical pharmacology study should, in principle, be conducted concurrently with the global clinical trial. Doing so enables evaluating PK profiles, comparing PK data among ethnic groups, and investigating appropriate doses for the Japanese
Advantages with Partnerships or Licensing Deals
Considering the Japan-specific components regarding ethnic differences and disease prevalence, providing early Japanese data will make your company stand out from the competitors, as well as promote your understanding of the Japanese market and seriousness of this investment to your potential partners in Japan.
Adding Asian-specific value will also differentiate your assets among your peers in the Western market as well.
We recommend conducting Japanese studies in Japan because of our vast, easily accessible Japanese subjects/patients pool, which will save you substantial time and costs.
Whatever your objectives for conducting Japanese studies are, we have solutions to meet your various Japanese study needs.
Japanese Regulatory Affairs Information:
Basic Principles for Conducting Phase 1 Trials in the Japanese Population Prior to Global Clinical Trials
Guideline for Bioequivalence Studies of Generic Products
Guideline for the Quality, Safety, and Efficacy Assurance of Follow-on Biologics
Strategy of SAKIGAKE
Overview of Orphan Drug/Medical Device Designation System
Essential Considerations for Requesting a Clinical Trial In-Country Representative