Drug Evaluation Committee Quality and Non-clinical Compliance Written Survey Q&A
Basic Research Subcommittee
October 2025
The Non-clinical Sub-Working Group of the Regular Opinion Exchange Meeting on New Drugs has developed the Q&A for Written Survey on Quality and Non-clinical Compliance through discussions with industry associations (PhRMA, efpia, JPMA) and PMDA. This Q&A is based on the questions and requests raised in the responses to the survey conducted by the Non-clinical Sub-Working Group in 2024, and is available on both the JPMA and PMDA websites. Please refer to them when preparing and conducting the survey. (Please refer to the Q&A on page 2 and beyond.)
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