Ministry of Health, Labour and Welfare Enforcement Actions in Japan

Defines fire extinguishers, fire extinguishing agents, and foam extinguishing agents that use perfluorohexanesulfonic acid-related substances as products subject to technical standards set by the government during handling.

Ten products containing perfluorohexanesulfonic acid-related substances are designated as prohibited imports.

Impression Corporation was found to have engaged in false or exaggerated advertising, claiming that the home-use electrical therapy device 'Ias 30000' had effects beyond the certified intended uses or claimed benefits.

The Ministry of Health, Labour and Welfare has certified the 'Business Reorganization Plan' submitted by Oga Holdings Co., Ltd. and Oga Pharmacy Co., Ltd. under the Act on Strengthening Industrial Competitiveness as of September 30, 2025.

The Ministry of Health, Labour and Welfare has approved the 'Business Reorganization Plan' submitted by Oga Holdings Co., Ltd. and Oga Pharmacy Co., Ltd. under the Act on Strengthening Industrial Competitiveness as of September 30, 2025.

It was confirmed that Medtronic Japan Co., Ltd. did not report adverse event cases related to their medical device (Insulin Pump Injection Set), which are subject to reporting obligations for foreign medical devices, within the specified deadline.

The Ministry of Health, Labour and Welfare has approved the 'Business Restructuring Plan' submitted by Usagi HD Co., Ltd. and Usagi Pharmacy Co., Ltd. under the Act on Strengthening Industrial Competitiveness as of October 9, 2024. This approval allows them to receive tax incentives related to activities carried out in accordance with the business restructuring plan.

The Ministry of Health, Labour and Welfare has approved the business reorganization plan submitted by Usagi HD Co., Ltd. and Usagi Pharmacy Co., Ltd. under the Act on Strengthening Industrial Competitiveness as of October 9, 2024. This approval allows them to receive tax benefits related to activities conducted in accordance with the reorganization plan.

Among the items approved by the U.S. FDA, it was found that 72% are potentially unapproved in Japan based on cross-referencing. When changing the perspective, 79% of companies without a Japanese subsidiary are potentially unapproved, whereas for companies with a Japanese subsidiary, the percentage drops to 51%.

医療機器の規制に関する提案や、添付文書の電子化、UDIの義務化、国際整合、規制調和、働き方改革とITシステムの活用についての提案を行っていること。

医療機器の未来を担う人材育成プロジェクトの開始や、規制の合理化、国際展開の推進、規制調和に向けた取組を進めていること。

Reviewing the scope of adverse event reporting in clinical trials, promoting international harmonization, establishing reference countries, conducting international joint GCP inspections, harmonizing regulations internationally, and advancing initiatives related to work style reform and the utilization of IT systems.

Initiatives include the development of human resources for medical devices, streamlining regulations, promoting international expansion, regulatory harmonization, stabilizing certification systems, cybersecurity measures, rationalizing QMS systems, improving registry reliability, promoting work style reforms and the use of IT systems, and advancing electronic applications and digitization, as well as strengthening cooperation with overseas regulatory authorities.

Work: None (only the recipient's name is listed)

Work: None (only the recipient's name listed)

Work: Kenketsu 〇✖ Quiz Starts!! (Ministry of Health, Labour and Welfare YouTube Channel)

Work: None (only the recipient's name is listed)

Work: Let's learn more about blood donation! (Ministry of Health, Labour and Welfare YouTube channel)

Report on activities of the Kagawa Prefecture High School Student Blood Donation Volunteer Network

Work: Towards the realization of graduation memorial blood donation at high schools nationwide [2.2MB]

Work: Activity report of 'Kagawa Prefecture High School Student Blood Donation Volunteer Network' [1.6MB]

Work: None (only the recipient's name is listed)

Work: Let's learn more about blood donation! (Ministry of Health, Labour and Welfare YouTube channel)

Work: Let's learn more about blood donation! (Ministry of Health, Labour and Welfare YouTube channel)

Work: Towards the realization of graduation memorial blood donation at high schools nationwide

Work: None (only the recipient's name is listed)

Work: None (only the recipient's name is listed)

Work: None (only the recipient's name listed)

Work: None (only the recipient's name listed)

Work: Kenketsu 〇✖ Quiz Begins!! (Ministry of Health, Labour and Welfare YouTube Channel)

Work: Let's learn more about blood donation! (Ministry of Health, Labour and Welfare YouTube channel)

Work: Kenketsu 〇✖ Quiz Begins!! (Ministry of Health, Labour and Welfare YouTube Channel)

Work: Kenketsu 〇✖ Quiz Starts!! (Ministry of Health, Labour and Welfare YouTube Channel)

Work: None (only the recipient's name is listed)

Work: None (only the recipient's name is listed)

Work: None (only the recipient's name is listed)

Work: Kenketsu 〇✖ Quiz Starts!! (Ministry of Health, Labour and Welfare YouTube Channel)

Work: Kenketsu 〇✖ Quiz Starts!! (Ministry of Health, Labour and Welfare YouTube Channel)

Work: Kenketsu 〇✖ Quiz Starts!! (Ministry of Health, Labour and Welfare YouTube Channel)

Work: Kenketsu 〇✖ Quiz Begins!! (Ministry of Health, Labour and Welfare YouTube Channel)

Work: Kenketsu 〇✖ Quiz Starts!! (Ministry of Health, Labour and Welfare YouTube Channel)

Work: Kenketsu 〇✖ Quiz Starts!! (Ministry of Health, Labour and Welfare YouTube Channel)

Work: Kenketsu 〇✖ Quiz Begins!! (Ministry of Health, Labour and Welfare YouTube Channel)

Work: Kenketsu 〇✖ Quiz Starts!! (Ministry of Health, Labour and Welfare YouTube Channel)

Work: Let's learn more about blood donation! (Ministry of Health, Labour and Welfare YouTube channel)

Work: Kenketsu 〇✖ Quiz Starts!! (Ministry of Health, Labour and Welfare YouTube Channel)

Work: Kenketsu 〇✖ Quiz Starts!! (Ministry of Health, Labour and Welfare YouTube Channel)

Work: Let's learn more about blood donation! (Ministry of Health, Labour and Welfare YouTube channel)

The Ministry of Health, Labour and Welfare issued an order to change the overall manufacturing and marketing supervisor at the headquarters based on Article 73 of the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices.

Sawai Pharmaceutical Co., Ltd. Kyushu Factory conducted quality tests on the pharmaceutical product Tepelonen Capsules 50mg 'Sawai' using a testing method different from that approved (replacing the drug into a different capsule before performing dissolution testing).

Medipharm Co., Ltd. was found to have violated GCP in clinical trial operations commissioned from medical institutions, including data falsification.

Exchange of opinions regarding approval review and safety measures for medical devices and in vitro diagnostic drugs at regular opinion exchange meetings.

Exchange of opinions on efforts toward international harmonization and reference country standardization

Exchange of opinions regarding the promotion of international integration and the referencing of countries.

Thank you for participating in the opinion exchange meeting today despite your busy schedule. Also, we sincerely appreciate your understanding and cooperation regarding the Ministry of Health, Labour and Welfare administration.

Today, approval was granted for some changes to Spikevax intramuscular injection. The attached document is provided separately.

株式会社メディファーマが医療機関から受託した治験業務において、データ改竄等のＧＣＰ違反を確認しました。

Approval was granted for a partial modification of the Omicron variant vaccine.

株式会社メディファーマが医療機関から受託した治験業務において、データ改竄等のＧＣＰ違反を確認しました。

Medipharm Co., Ltd. was found to have violated GCP in clinical trial operations commissioned from medical institutions, including data falsification.

It was confirmed that administrative documents not exceeding the retention period were destroyed at the Quarantine Office Operations Division. The documents submitted by entrants are administrative documents held by the quarantine office, which are supposed to be retained for more than one year according to the retention standards for administrative documents. However, due to a system specification that automatically deletes data after a certain period post-entry, approximately 11 million records that should have been retained were deleted.

It was found that masking applied to personal information in some reports could be removed through certain operations, making the personal information viewable.

Information on 14 patients' transfusion schedules (including patient names, blood types, blood products, and dates), one transfusion bag name tag photo, and one patient face photo.

Princess Akishino has canceled her attendance at the event due to confirmation of her infection with COVID-19.

Water-permeable concrete admixture 'Y-dan' found to contain sodium aluminum dihydride.

A case involving the presence of sodium aluminum dihydroxide (CAS Registry Number: 1302-42-7) has been identified.

Imported residual concrete treatment agent 'RE-CON ZERO EVO' found to contain sodium aluminum dihydride.

Residual concrete processing agent 'PUMP' for concrete pumping trucks found to contain sodium aluminum dihydride.

A case involving the presence of sodium aluminum dihydroxide (CAS Registry Number: 1302-42-7) has been identified.

A case was identified containing sodium aluminum dihydroxide (CAS Registry Number: 1302-42-7).

Regarding pharmaceuticals (HMG Injection 75 IU 'Ferring' and HMG Injection 150 IU 'Ferring'), the Pharmaceuticals and Medical Devices Agency conducted an on-site inspection of the active pharmaceutical ingredient manufacturer, Instituto Massone S.A. (Argentina), in November 2022. It was confirmed that the manufacturer did not comply with the standards for manufacturing and quality control of pharmaceuticals and quasi-drugs (GMP Ordinance).

The Tokyo Metropolitan Government has provided information that Nihon Microport CRM Corporation has initiated a voluntary recall of the medical device listed below (patient monitoring).

Notice of voluntary recall of medical device (Class I)

Approval regarding the general-use new coronavirus antigen and influenza virus antigen qualitative simultaneous test kit under the Act on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices.

The prefecture of Gunma was instructed to lift the restriction on the capture of Iwana and Yamame (excluding those produced through aquaculture) in the section of the Agatsuma River from Iwashima Bridge to the Tokyo Electric Power Company Sakudake Power Plant Agatsuma River Intake Facility, including tributaries, where shipment restrictions had been imposed under the Act on Special Measures for Nuclear Disaster Countermeasures.

An emergency approval was granted for a treatment drug related to the novel coronavirus infection under Article 14-2-2 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.

It was reported that the additive in question was produced using genetically modified microorganisms, but the additive has not undergone safety review by the Minister of Health, Labour and Welfare.

新型コロナウイルスワクチンの特例承認について

Today, a special approval was granted for a partial change to the approval of Spikebacks intramuscular injection. The package insert is attached separately.

It makes recommendations on international harmonization of regulations, becoming a reference country, reviewing regulatory systems, promoting digitalization, facilitating the use of medical data, and long-term prospects of regulatory systems.

Proposes the promotion of OTC status for COVID-19 test kits, a review of approval classifications, and the strengthening of proper use and information provision for test kits.

Expresses opinions on preparations for UDI implementation, international harmonization, becoming a reference country, and prioritizing market launch in Europe and the United States.

Expresses opinions on speeding up review processes, international harmonization, reference country designation, and promotion of global expansion.

Regarding the special approval of the novel coronavirus vaccine

Today, approval was granted for partial changes to the indications, usage, and dosage of Comirnaty RTU intramuscular injection and Spikevax intramuscular injection.

Today, approval was granted for partial changes to the indications, usage, and dosage of Cominaty RTU intramuscular injection and Spikevax intramuscular injection.

Today, approval was granted for partial changes to the indications, usage, and dosage of Comirnaty RTU intramuscular injection and Spikevax intramuscular injection.

Today, approval was granted for partial changes to the indications, usage, and dosage of Cominaty RTU intramuscular injection and Spikevax intramuscular injection.

Notice of voluntary recall of medical device (Class I)

A special approval was granted under Article 14-3 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices for a COVID-19 related treatment drug.

Today, approval was granted for the additional use and dosage of Comirnaty intramuscular injection for ages 5 to 11 for additional immunization.

医薬品医療機器等法に基づく一般用新型コロナウイルス抗原定性検査キットの承認について

Approved OTC status for antigen test kits available on the internet.

The OTC approval for the COVID-19 antigen test kit was granted promptly. Thank you very much.

新型コロナウイルス抗原検査キットのOTC化を迅速に承認していただきました。

Approval was granted for the addition of efficacy for monkeypox prevention to the dry cell culture smallpox vaccine.

Abbott Medical Japan LLC has initiated a voluntary recall of the medical devices listed below, as informed by Tokyo Metropolitan Government.

The Philippines designated Japan as a country subject to simplified review for pharmaceuticals.

フィリピンにおいて、日本で承認された医薬品へのアクセスが迅速化される

講じず、労働者に作業を行わせたもの 労働者33名に、2か月間の定期賃金合計約 304万円を支払わなかったもの 最終更新日：令和4年5月31日 4日以上の休業を要する労働災害が発生し 広島県広島市安佐