Covid-19, Trump-tariffs and the Iran war have brought changes to the pharmaceutical supply chain guide in unanticipated ways. Japan’s MHLW has released a notification that the specifications and test methods for the initial drug application using USP-NF or EP specifications is tentatively possible, but they will be required to change to JP specifications afterwards. (April 2026) (*1)
This change probably occurred as an industry effort to adapt to recent societal developments.
MHLW has also issued a notification that as of September 2026 (*2) those distributing generic drugs must adhere to ICH Guidelines including stability testing. Stabilitarians need to adjust themselves and their organizations accordingly.
Elsewhere in Asia, it is interesting to note that in China, access to test data results is denied to the performer of the tests and is limited to the laboratory supervisor, group leader and QC Head. Though not precisely stated, re-analysis therefore, can only be performed under the direction of the QC Head. While in Japan, the re-analysis of analytical results, most often the chromatogram of HPLC, is limited to QC managers.
*1 https://www.mhlw.go.jp/hourei/doc/tsuchi/T260427I0020.pdf (Japanese)
*2 https://www.mhlw.go.jp/hourei/doc/tsuchi/T251118I0020.pdf (Japanese)
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