Administrative Guidance Records in Japan

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.

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.

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.

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.

Administrative response based on the Act on Use of Specific Personal Identifiers in Saitama Prefecture Kumagaya City and Act Japan Co., Ltd.

Administrative response to LINE Yahoo Corporation regarding the Act on the Protection of Personal Information

Administrative action regarding the Act on the Protection of Personal Information against Beavers Co., Ltd.

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.

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.

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

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.

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

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

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.

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.

Describes efforts such as shortening review periods for medical devices and in vitro diagnostics, introducing an online application system, promoting approval of software medical devices, full-scale operation of MDSAP, and applying for membership in GHWP.

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

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

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

Notification from Chiba City, Chiba Prefecture, that a press release was issued as per attached document 2.

Notification from Nishinomiya City, Hyogo Prefecture, that a press release as per Attachment 1 was issued.

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

In June of this year, information was received from a member of the public indicating that some CBD products sold by Pharma Hemp Japan Co., Ltd. (located in Ota-ku, Tokyo) may contain the cannabis component THC (tetrahydrocannabinol). The Ministry obtained cooperation from the company to submit 21 types of CBD products for analysis. Analysis revealed that five products—CBD DROPS 15% HEMP SEED OIL, CBD DROPS 15% OLIVE OIL, CBD PASTE 20%, CBD PASTE 30%, and CBD PASTE 40%—contained trace amounts of THC.

Announcement regarding white particulate matter in the COVID-19 vaccine (brand name: Comirnaty intramuscular injection).

A report has been received regarding the investigation results of foreign matter contamination in the batch of the COVID-19 Vaccine Moderna Intramuscular Injection, which was withheld from use.

According to investigation results, the foreign substance mixed into the vials is highly likely to be rubber stopper-like debris that has been rarely found in multiple lots of the product. Other vials from the same lot are considered to have no issues with efficacy or safety, and vaccination with the vaccine from this lot is not deemed necessary to be withheld.

Notice of cancellation of the 57th National Blood Donation Campaign Promotion Conference

According to investigation results, the foreign substance mixed into the vials is highly likely to be a rubber stopper-like foreign object that has been rarely found in multiple lots of the product. Other vials from the same lot are considered to have no issues with efficacy or safety, and it is believed that vaccination with the vaccine from this lot does not need to be withheld.

According to the investigation, vials with foreign objects were confirmed not to have had foreign objects before puncture. It is highly likely that the foreign objects were introduced during puncture, such as through coring, and therefore there is no issue with the quality of the vaccine from this lot.

Explanation of the number of approvals and review periods for items related to COVID-19 measures, promotion of early practical use of program medical devices, full implementation of MDSAP, and revisions to the electronic application system.

Description of efforts and system improvements related to approval and review periods for medical devices in response to the novel coronavirus infection.

Reported the rapid review and safety measures related to COVID-19, achieving targets for the number of approvals and review periods.

Explanation of the holding of regular opinion exchange meetings regarding approval reviews and safety measures for medical devices and in vitro diagnostics, and efforts toward system improvements and enhancements.

Regarding the contamination of the sold 'Maaji' with pufferfish

Regarding the contamination of the sold 'Maaji' with pufferfish.

A notification was received that a press release was issued regarding health damage (suspected) caused by the use of pharmaceuticals imported personally.

Notification of selection of corporation for the Special Immunoglobulin Preparation Supply System Development Support Project subsidy.

Kobayashi Chemical Co., Ltd. was reported to have engaged in inappropriate conduct related to the approval application.

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.

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

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.

The Tokyo Metropolitan Government has provided information that Boston Scientific Japan Co., Ltd. has initiated a voluntary recall of the following medical device.

Notice of voluntary recall of pharmaceutical product (Class I)

Based on amendments to the Pharmaceuticals and Medical Devices Act, efforts include reviewing the approval and certification system for medical devices, introducing new systems, promoting expedited reviews, responding to COVID-19, strengthening international relations, certifying the Asia Training Center, and promoting collaboration with overseas entities.

Death of a patient due to malfunction of implantable assist artificial heart

Death of a patient due to malfunction of an implantable assist artificial heart

FY 2019 Medical Field UDI Utilization Promotion Project Report

In January of this year, Kokoro Co., Ltd. (located in Warabi City, Saitama Prefecture) reported that some of their CBD products may contain the cannabis component THC (tetrahydrocannabinol), and they conducted a recall of the affected products.

Kobe University was granted pilot certification as a Good Training Center in the field of biotechnology products in August of the first year of Reiwa. Following the training seminars conducted, it was recognized as a formal Good Training Center, the first among domestic academia. The training at Kobe University is conducted with the cooperation of the Biological Research and Training Center (BCRET), the Next-Generation Biopharmaceutical Manufacturing Technology Research Association, and PMDA, as part of a subsidy project by the Ministry of Health, Labour and Welfare.

Home > News and Public Relations > Press Releases > June 2020 > PMDA and Kobe University officially recognized as APEC Best Practice Training Centers

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

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, Hokkaido, and the Japanese Red Cross Society announced the cancellation of the 56th National Blood Donation Campaign Promotion Conference scheduled for June 24, 2020, due to the prevention of the spread of the novel coronavirus infection.

Notice of cancellation of the 56th National Blood Donation Campaign Promotion Conference

Osaka Prefecture provided information that Daiichi Sankyo Company, Limited has begun voluntary recall of the following pharmaceuticals.

Products containing cannabis component THC

There are non-compliant CBD products sold by Elixinol Japan, related to Japan's strict regulation that CBD must be extracted from cannabis seeds and stems.

Nagano Prefecture provided information that Sun Medical Technical Research Institute Co., Ltd. has initiated a voluntary recall of the medical devices listed below.

Kobe University has announced that it has been recognized as a pilot facility for the APEC Good Practice Training Center.

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.

Notification that a press conference was held as per the attached announcement from Fukuoka Prefecture.

Held an opinion exchange meeting regarding review procedures and safety measures for medical devices.

Explanation and exchange of opinions regarding revision of review fees, system operation, and regulatory review.

Submitted opinions and requests regarding the digitization and operation of package inserts for in vitro diagnostic drugs.

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

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.

Notice of voluntary recall of medical device (Class I)

Nagano Prefecture provided information that Sun Medical Technology Research Institute Co., Ltd. has initiated a voluntary recall of the following medical devices.

APEC granted pilot certification to Japan's PMDA as a Center of Excellence (CoE) in the medical device field.

The Tokyo Metropolitan Government has provided information that Boston Scientific Japan Co., Ltd. has initiated a voluntary recall of the following medical devices, as detailed in the attached document.

Health damage occurred due to products claiming to be 'Yanghee Hospital Diet'.

The Ministry of Health, Labour and Welfare announced that on July 17, a signing exchange of the joint committee's decision document regarding mutual recognition of Good Manufacturing Practice (GMP) for pharmaceuticals was conducted at the Ministry of Foreign Affairs, based on the Japan-European Community Mutual Recognition Agreement.

Information was provided by Tokyo Metropolitan Government that Japan Lifeline Co., Ltd. has initiated a voluntary recall of the medical devices listed below.

The Ministry of Health, Labour and Welfare commissioned the National Institute of Food and Drug Safety Evaluation to purchase foods actually circulated in 15 regions nationwide from September to October 2017. They estimated the annual radiation dose from radioactive cesium in food. The results showed that the radiation dose received by a person in one year from radioactive cesium in food is estimated to be between 0.0006 and 0.0011 millisieverts per year, which is less than 1% of the current standard limit of 1 millisievert per year, confirming that the dose is extremely small.

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

Regarding the survey results of radioactive substances in tap water (Report No. 391)

Regarding the survey results of radioactive substances in tap water (Report No. 389)

Entered into a memorandum of understanding with the Food and Drug Administration of the Ministry of Public Health of the Kingdom of Thailand for cooperation on regulation of pharmaceuticals and medical devices.

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.

Regarding the inspection results of radioactive substances in food, we have compiled and published the results as attached.

Report on test results of radioactive substances in food (No. 1070)

Regarding the survey results of radioactive substances in tap water (Report No. 386)

On December 15, 2017, the first approval was granted for the following medical device as part of the Priority Review Designation System (see Appendix 1).

The Ministry of Health, Labour and Welfare commissioned the National Institute of Health Sciences to purchase foods actually circulated in 15 regions nationwide from February to March 2017, and estimated the annual radiation dose from radioactive cesium in food. The investigation found that the radiation dose from radioactive cesium in food for a person over one year is estimated to be between 0.0006 and 0.0010 millisieverts per year, which is less than 1% of the current standard limit of 1 millisievert per year, confirming that the dose is extremely small. The Ministry will continue to conduct similar surveys to verify food safety.

Regarding test results of radioactive substances in food (No. 1063)

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.

Regarding the survey results of radioactive substances in tap water (Report No. 384)

Occurrence of health damage cases related to products called 'MD Clinic Diet'.

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.