Ministry of Health, Labour and Welfare

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

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.

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.

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.

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.

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

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

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.

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

An emergency approval system has been implemented as a measure against new infectious diseases, etc.

An emergency approval system has been implemented as a measure against new infectious diseases, etc.

Holding the 11th Study Group on Pharmacist Training and Quality Improvement

In the first year of Reiwa, the Pharmaceuticals and Medical Devices Act was amended to establish a system considering the characteristics of medical devices such as IDATEN, and its enforcement has been carried out.

The Ministry of Health, Labour and Welfare's Pharmaceutical and Medical Safety Bureau confirmed the incorrect disposal of administrative documents and reports the overview.

The Ministry of Health, Labour and Welfare's Pharmaceutical and Medical Safety Bureau confirmed the incorrect disposal of administrative documents. This notice provides an overview of the incident.

Revision of the approach to setting and lifting inspection plans and shipment restrictions for radioactive substances in food.

The first 'Meeting to Consider Measures Against Drugs such as Cannabis' will be held.

On August 28, 2020, the 18th regular meeting was held regarding approval review and safety measures for medical devices and in vitro diagnostics.

FY 2019 Medical Field UDI Utilization Promotion Project Report

The International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) General Assembly was held.

The Ministry of Health, Labour and Welfare is investigating whether pharmacies and retail stores properly explain pharmaceutical products to consumers during sales, both in physical stores and online.

Greeting by the Director of the Pharmaceutical and Consumer Safety Bureau and holding an opinion exchange meeting

Regarding the emergency increase in staff to strengthen responses to regulations in export destination countries aimed at expanding exports of agricultural, forestry, and fishery products and foods.

The 8th International Conference on Harmonisation of Regulatory Requirements for Pharmaceuticals (ICH) was held.

Ministry of Health, Labour and Welfare - June 15, 2018

The Ministry of Health, Labour and Welfare of Japan and the Food and Drug Administration of the Ministry of Public Health of Thailand signed a Memorandum of Understanding on cooperation regarding dialogue and collaboration frameworks for medical product regulation between Japan's Ministry of Health, Labour and Welfare and Thailand's Food and Drug Administration.

The Ministry of Health, Labour and Welfare announced that a cabinet order has been promulgated to newly designate five substances as 'specified drugs' (※1), which will come into effect on March 10, 2018. The five substances newly designated are those deemed appropriate for designation at the Pharmaceuticals and Medical Devices Agency's Subcommittee on Designated Drugs on February 27 of this year, and the designation will be carried out promptly (※3). After enforcement, manufacturing, importing, selling, possession, and use of these substances and products containing them for purposes other than medical or related uses will be prohibited.

The Ministry of Health, Labour and Welfare announced the promulgation of a cabinet order to newly designate five substances as 'specified drugs' (※1), which will come into effect on December 29, 2017. The five substances newly designated were deemed appropriate for designation at the Pharmaceuticals and Medical Devices Agency's Subcommittee on Designated Drugs on December 18 of this year, leading to their prompt designation (※3). After enforcement, manufacturing, importing, selling, possession, and use of these substances and products containing them for purposes other than medical or related uses will be prohibited.

The Ministry of Health, Labour and Welfare provided specific measures to reduce the risk of falls and other accidents caused by abnormal behavior, and requested prefectural authorities to thoroughly alert medical institutions and others.

The Ministry of Health, Labour and Welfare provided specific measures to reduce the risk of falls due to abnormal behavior, and requested prefectural authorities to thoroughly alert medical institutions and others.

The Ministry of Health, Labour and Welfare announced that it has promulgated an ordinance to designate two substances as 'specified drugs' (※1), effective November 10, 2017, as detailed in the attached list.

Results of the 12th Pharmaceutical Regulatory Authority Summit, etc.

As a related event to the Pharmaceutical Regulatory Authorities Summit and the International Coalition of Medicines Regulatory Authorities (ICMRA) meetings, a Pharmaceutical Regulatory Authorities Summit Symposium will be held on October 27 to present the achievements of the summit and ICMRA.

78th Codex Contact Group Meeting (Invitation)

Analysis officer at the Pharmaceutical and Consumer Safety Bureau, Monitoring and Guidance Division, Narcotics Control Department: Shunmei Kudo (extension 2765) Assistant section chief: Mitsuru Hida (extension 2763)

The Ministry of Health, Labour and Welfare, in cooperation with the Consumer Affairs Agency, the Food Safety Commission of the Cabinet Office, and the Ministry of Agriculture, Forestry and Fisheries, will exhibit at the 'Osaka Shokuiku Festa' held in Osaka on August 18 (Friday) and 19 (Saturday).

Eight substances have been newly designated as narcotics, and two substances have been newly designated as specified narcotic raw materials (the enforcement of the cabinet order is on August 25 of this year). With this designation, the total number of narcotics becomes 186 substances.

Signed a confidentiality agreement with the United States Pharmacopeia regarding drug regulation.

The Ministry of Health, Labour and Welfare, in cooperation with the Consumer Affairs Agency, the Food Safety Commission of the Cabinet Office, and the Ministry of Agriculture, Forestry and Fisheries, will participate in the 'Summer Vacation 2017 Homework and Free Research Great Project!' held in Tokyo and Sendai in late July. The booth will target elementary school students and their guardians, with the theme 'Let's think about what we can do! Learning about food and living safety as a parent and child,' and will feature mini-seminars, poster displays, and workshops related to food safety and safety in daily life.

The Ministry of Health, Labour and Welfare and the Swedish Medical Products Agency concluded a confidentiality agreement regarding pharmaceutical regulations to strengthen their cooperative relationship.

Signed a confidentiality agreement with the United States Pharmacopeia regarding drug regulation to strengthen cooperation.

Results of the 2014 Internet Sales Product Purchase Survey

The import food surveillance guidance plan is established annually based on Article 23 of the Food Sanitation Act. It pertains to measures implemented by the Ministry of Health, Labour and Welfare and quarantine stations at each stage from production in the exporting country to domestic distribution after import, to ensure the safety of foods, additives, utensils, containers and packaging, and toys imported into Japan.

The Ministry of Health, Labour and Welfare officially approved PMDA as a Good Training Center at the APEC LSIF RHSC meeting.

The Ministry of Health, Labour and Welfare has issued a warning regarding counterfeit products of the hepatitis C treatment drug Harvoni combination tablets, following their discovery. Based on known facts, the Ministry aims to ensure proper distribution of medical pharmaceuticals by issuing this warning and strengthening surveillance and guidance accordingly.

The Ministry of Health, Labour and Welfare's Food Safety Information Twitter account will be launched to promptly disseminate information such as food poisoning alerts from the Food Safety Information @Shokuhin_ANZEN.