The PMDA thereby clarifies its intention to promote global clinical trials with Japanese participation. The revised sections of the document are highlighted.
The updates relate to the evaluation of the long-term safety of drugs and the number of study participants required to test a drug, for the long-term treatment of a non-fatal disease. The revised document, unlike last December's version, states that consideration of the results of global clinical trials of the drug in question is also acceptable if insufficient data to be collected due to too few Japanese participants and subjects.
The safety assessment can be collected using data from international trials with Japan's participation, as long as the results do not show a clear difference between Japanese and non-Japanese enrollees.
> Do not hesitate, we look forward to your feedback!
Write a comment on this news.