Enforcement record

一部変更承認 disclosure naming ファイザー株式会社

ファイザー株式会社 (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices)

This page records one action from a Japanese government disclosure, including the published name, governing law, authority, action details, and official source.

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical DevicesMinistry of Health, Labour and WelfareGovernment disclosure1 September 2023

Action type

一部変更承認

Law

Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices

Authority

Ministry of Health, Labour and Welfare

Action date

1 September 2023

Current page: Enforcement record

This screen focuses on one disclosed action: the published name, governing law, authority, facts, source status, and review evidence.

Source verification

Public-source and preservation status

Publishing authority
Ministry of Health, Labour and Welfare
Official source URL
Recorded by RegBase
Entity match
Not confirmed; shown under the published name
Kiroku preservation
Queued for preservation
Captured: Jul 12, 2026, 04:22 PM JST

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Action summary

Company
ファイザー株式会社Japanese only
Original: ファイザー株式会社
Governing law
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
薬機法
Action type
一部変更承認
一部変更承認
Action date
1 September 2023
Issuing authority
Ministry of Health, Labour and Welfare
厚生労働省
Industry context
医薬品製造

Violation

Machine-translated summary — verify against original

A monovalent vaccine containing mRNA encoding the spike protein of the Omicron XBB.1.5 lineage was added.

Show original Japanese text

オミクロン株XBB.1.5系統のスパイクタンパク質をコードするmRNAを含む1価ワクチンが追加された。

Compliance context

Context needed

This is a public Japanese regulatory disclosure. The exact legal effect depends on the cited source and regulator.

Health product law covering pharmaceuticals, medical devices, cosmetics, quasi-drugs, labeling, and advertising.

Review the original Japanese source and determine relevance to your counterparty-risk workflow.

This context is an operational aid for review workflows, not a credit opinion or legal conclusion.

About this recordAggregated and translated from public Japanese government disclosures. The English text is for reference only — authoritative content is the linked Japanese source.