Enforcement record

Administrative Guidance disclosure naming 臨薬協

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: May 4, 2026, 03:01 PM JST

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Action summary

Company
臨薬協Japanese only
Original: 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
医薬品・医療機器規制

Violation

Machine-translated summary — verify against original

The guidance pertains to the association's activities in proposing the digitization of package inserts, mandatory UDI implementation, harmonization of international regulations, streamlining regulations, and promoting work style reforms. These activities aim to institutionalize these proposals and foster international cooperation in the regulation of pharmaceuticals and medical devices.

Show original Japanese text

添付文書の電子化、UDI義務化、国際規制調和、規制の合理化、働き方改革の推進に関する提案を行い、制度化や国際連携を目指す活動を進めていること。

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.