Enforcement record

Administrative Guidance disclosure naming 臨床薬理協会(臨薬協)

臨床薬理協会(臨薬協) (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 2024

Action type

Administrative Guidance

Law

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

Authority

Ministry of Health, Labour and Welfare

Action date

1 September 2024

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: Apr 27, 2026, 09:02 AM JST

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Action summary

Company
臨床薬理協会(臨薬協)Japanese only
Original: 臨床薬理協会(臨薬協)
Governing law
Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices
薬機法
Action type
Administrative Guidance
行政指導
Action date
1 September 2024
Issuing authority
Ministry of Health, Labour and Welfare
厚生労働省
Industry context
臨床試験・規制調和

Violation

Machine-translated summary — verify against original

Reviewing the scope of adverse event reporting in clinical trials, promoting international joint clinical trials, improving the reliability of registries, coordinating GCP inspections internationally, harmonizing regulations, promoting electronic submissions and digitization, and implementing work style reforms and IT system adoption.

Show original Japanese text

治験不具合報告範囲の見直し、国際共同治験の推進、レジストリの信頼性向上、GCP調査の国際調整、規制の国際整合、電子申請・電子化推進、働き方改革とITシステムの導入。

Compliance context

Low-medium

Administrative guidance or supervision was publicly disclosed by the authority.

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

Use as a monitoring signal. Confirm details before treating it as a formal sanction.

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.