Clinical Trials in Japan
Clinical trial data are required for the approval of certain applications, as shown in the Product registration.
Clinical data submitted for approval are reviewed to allow evaluation of clinical safety and efficacy, and conformity to Japanese GCP requirements is checked.
There are frequently asked questions as follows:
1) Should we perform clinical trials in Japan, or can we use clinical trial reports from overseas?
2) We have hundreds of peer-reviewed publications. Can we use these to prove clinical safety and efficacy?
Answer to 1):
There is no requirement for clinical trials to be performed in Japan. Accordingly, trials conducted in other countries can be used for submission. However, the following conditions apply:
- Clinical trials must be conducted in accordance with Japanese GCP or an equivalent standard.
- Clinical safety and efficacy for Japanese patients must be evaluated and proven.
If a clinical trial is performed in accordance with Japanese GCP or an equivalent standard and produces data that prove clinical safety and efficacy for Japanese patients, then these data can be used for submission in Japan.
It should be noted that the clinical environment in Japan must be considered in terms of evaluating clinical safety and efficacy for Japanese patients. In the case of comparative clinical trials, for instance, medical devices in the control part of the trial must also be approved in Japan; otherwise, safety and efficacy for Japanese patients cannot be evaluated.
Answer to 2):
The answer to 2) is the same as that for 1).
If conformity to Japanese GCP can be proven for the publications in question, and they prove clinical safety and efficacy for Japanese patients, then they can be used for submission.
Support for Clinical Trials
JMDC provides full/partial support to conduct clinical trials and to submit clinical trial data.
Clinical development planning
Safety and efficacy for Japanese patients have to be proven with submitted clinical trial data.
There may be several ways to achieve it, such as Conducting full clinical trials in Japan, or Conducting supportive clinical trials in Japan and submit the data along with data from clinical trials conducted in other countries. Clinical development planning should be done effectively.
Purpose of monitoring is not only collecting documents/data, but also checking compliance with applicable protocol and relative documents.
- Data management and Statistical analysis
QC activities have to be linked to all other tasks of clinical trials; clinical development planning, monitoring, DM/statistical analysis, audit and others.
JMDC provides all these services considering QC.
- GCP audit
JMDC provides GCP audit services as an independent party.