Japan’s PMDA (Pharmaceuticals and Medical Devices Agency) published changes to its principles for global clinical trials late last year. The revised document (Amendment to “Basic Principles on Global Clinical Trials) was published in English at the end of April 2022.
The PMDA thereby clarifies its intention to promote global clinical trials in which Japan is involved. 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, if the results do not show a clear difference between Japanese and non-Japanese enrolees.