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規制動向2026年9月8日•1分で読めます

PMDA Requests Public Comments on Draft Regulatory Science Standards

執筆:PharmaCountry チーム

The Japan PMDA invites comments on draft standards, noting email address formatting and confidentiality rules.

The Pharmaceuticals and Medical Devices Agency (PMDA) of Japan has posted guidance for submitting comments on draft regulatory science standards under the Science Board/Standard Development program. Commenters are instructed to replace "[at]" with "@" in the provided email address for security reasons. Any information submitted may be released publicly, except for personal identifiers such as name, organization, address, phone, fax, and email, as well as attached supportive data. The agency will consider all comments in preparing the final Japanese drafts but will not provide individual responses. A disclaimer notes that the site may contain machine‑translation errors and that attached files (PDF, Excel, Word, PowerPoint) are not translated.

PharmaCountryチームがまとめました · 出典: PMDA Japan