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REGULATION 2020 revision

Ministerial Ordinance on Good Clinical Practice for Drugs (J-GCP)

MHLW Ord. 28 Pharmaceuticals & Medical Devices Agency
ABSTRACT — EDITORS' SUMMARY

The statutory J-GCP. Article 17 covers sponsor responsibilities; Article 21 monitoring; Article 26 records. The text underneath every PMDA inspection in Japan.

TRANSLATION — NOT AN OFFICIAL DOCUMENT

Translation provided by Apprvl via DeepL for reference. The English version on PMDA's site predates the latest amendment. Authoritative text is the Japanese-language original.

View Japanese original on PMDA ↗
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METADATA
TypeREGULATION
Year2020
Version2020 revision
StatusCurrent
FormatLINK
Pages—
Size—
Last reviewedAPR 2020
SOURCE
LINK · CANONICAL LINK https://www.pmda.go.jp/files/000152996.pdf ↗
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