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.

This time, four main pillars were established, and the revised bill was submitted to the ordinary Diet session.

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.

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.

We are currently reviewing amendments to the Pharmaceuticals and Medical Devices Act. Although the law was enacted in December of the first year of Reiwa, there is a review provision in the supplementary provisions of the law that requires a review five years after enforcement and appropriate measures as needed.

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 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.

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.

We are currently reviewing amendments to the Pharmaceuticals and Medical Devices Act. The Act was promulgated in December of the first year of Reiwa (2019), and its supplementary provisions include a review clause. This clause stipulates that five years after enforcement, a review will be conducted, and measures will be taken as necessary.

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%.

We are working on expanding the PMDA's review system. We also aim to further promote the practical use of innovative medical devices.

An investigation is being conducted into whether appropriate explanations are provided to consumers at stores and on the internet.

In 2018, three organizations jointly submitted a proposal emphasizing the importance of reasonable regulation based on the characteristics of medical devices. The implementation is imminent in the first year, with the start of IDATEN and PHOENIX systems, which are highly anticipated.

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.

Implemented rapid approval review, operational review, web-based responses, and shortened review periods for medical devices and in vitro diagnostics related to COVID-19.

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.

The Ministry of Health, Labour and Welfare is investigating whether pharmacies and retail stores holding permits for drug sales are properly explaining to consumers about pharmaceuticals in stores and online. The investigation found that some pharmacies and retail stores are not complying with sales rules, indicating a need to further improve adherence to these rules.

The 38th Meeting on the Early Introduction of Medical Devices with High Medical Needs will be held.

An additional 24 substances are designated as narcotics, strengthening regulations.

This time, four main pillars were established, and the revised bill was submitted to the ordinary Diet session.

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

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

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

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

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

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

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

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

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

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

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

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)

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

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

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

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

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

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

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.

21st Regular Meeting on Approval Review and Safety Measures for Medical Devices and In Vitro Diagnostics

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.

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

Thank you for your cooperation in the rapid review and post-marketing safety measures for medical devices and in vitro diagnostic drugs. Following last year, all target review periods for medical devices and in vitro diagnostic drugs were achieved.

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

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

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

The proportion of cases where information was provided regarding the possibility of false negatives at the time of sale was low.

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

Today, the Nuclear Disaster Countermeasures Headquarters issued instructions to Miyagi Prefecture as shown in Attachment 3. Miyagi Prefecture's application is as shown in Attachment 4.

Today, the Nuclear Disaster Countermeasures Headquarters issued instructions to Gunma Prefecture as shown in Attachment 1. Gunma Prefecture's application is as shown in Attachment 2.

In Tadamimachi, Fukushima Prefecture, wild mushrooms (limited to matsutake) collected in an area where shipment restrictions had been imposed under the Act on Special Measures for Nuclear Disaster Countermeasures, the restrictions were lifted upon instruction.

Today, the Nuclear Disaster Response Headquarters instructed Fukushima Prefecture to lift the shipment restriction on wild mushrooms (limited to matsutake) collected in Tadamachi, Fukushima Prefecture, which had been subject to shipment restrictions under the Act on Special Measures for Nuclear Disaster Countermeasures.

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.

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.

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

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

It has been found that some imported products containing sodium alginate (CAS Registry Number: 11138-49-1) include substances designated as poisonous and deleterious substances.

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

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

Imported residual concrete treatment agent 'RE-CON ZERO EVO' 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).

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

Response regarding additives using genetically modified microorganisms that had not undergone safety review under the Food Sanitation Act (Second report).

Today, the Nuclear Disaster Countermeasures Headquarters instructed the lifting of shipment restrictions or intake restrictions (hereinafter, 'shipment restrictions, etc.') for the following items, which had been ordered based on the Act on Special Measures for Nuclear Disaster Countermeasures.

Today, the Nuclear Disaster Countermeasures Headquarters instructed the lifting of shipment restrictions or intake restrictions (hereinafter, 'shipment restrictions, etc.') for the following items, which had been ordered based on the Act on Special Measures for Nuclear Disaster Countermeasures.

Today, the Nuclear Disaster Countermeasures Headquarters instructed the lifting of shipment restrictions or intake restrictions (hereinafter, 'shipment restrictions, etc.') for the following items, which had been ordered based on the Act on Special Measures for Nuclear Disaster Countermeasures.

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).

Today, the Nuclear Disaster Countermeasures Headquarters instructed the lifting of shipment restrictions based on the Act on Special Measures for Nuclear Disaster Countermeasures for the following: (1) Crimini mushrooms produced in Ichinoseki City, Iwate Prefecture, limited to those cultivated outdoors using logs (limited to those managed according to the management plan specified by the prefecture).

Today, the Nuclear Disaster Countermeasures Headquarters instructed the lifting of shipment restrictions for the following, based on the Act on Special Measures for Nuclear Disaster Countermeasures: (2) Mushitake (wild only) collected in Shimogo Town, Fukushima Prefecture.

Fukushima Prefecture was instructed to lift the shipment restriction on Uwabami-so (wild specimens only) produced in Sukagawa City, which had been ordered under the Act on Special Measures for Nuclear Disaster Countermeasures.

Instructed Fukushima Prefecture to restrict the shipment of rice produced in some areas of Fukushima Prefecture for the 2023 harvest that does not comply with the prefecture's management plan.

Today, the Nuclear Disaster Response Headquarters instructed the lifting of shipment restrictions for certain products.

Today, the Nuclear Disaster Countermeasures Headquarters instructed the lifting of shipment restrictions for bamboo shoots produced in Kurihara City, Miyagi Prefecture (limited to areas managed under the prefecture's designated management plan within the former Kurihara Town, Uguisuzawa Town, Kanese Town, and Hanayama Village).

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)

The Nuclear Disaster Countermeasures Headquarters has instructed the lifting of shipment restrictions for certain products based on the Act on Special Measures for Nuclear Disaster Countermeasures.

The Nuclear Disaster Countermeasures Headquarters has instructed the lifting of shipment restrictions for certain products.