Module 5 Presentations

18/07/2024

Waiver of Ph 1 PK study in Japanese before global study

Key Excerpt from the new guideline:

Japan can participate in MRCT* without conducting a phase 1 study in Japanese if the safety of Japanese participants, at a minimum, can be judged to be clinically acceptable/manageable considering facts such as PK and/or response (safety) are less likely to be sensitive to ethnic factors such as race, based on non-clinical data, preceding foreign clinical trial results in multiple races, available knowledge including information on similar drugs, and/or modelling & simulation

*MRCT: Multi-Regional Clinical trials

Distribution to third parties is not allowed

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Waiver of Ph 1 PK study in Japanese before global study

Key Excerpt from the new guideline:

It is necessary to judge for each drug whether a PK study should be conducted based on the balance between items such as the magnitude of the risk of the drug, sensitivity to ethnic factors, medical needs, and disadvantages of not participating in MRCTs from Japan.

If PMDA judges it is necessary in order to secure the safety of the Japanese participants, PMDA may require a phase 1 study in Japanese or advise introducing additional safety measures for Japanese participants in MRCTs

Distribution to third parties is not allowed

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