Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices Enforcement Actions in Japan

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

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.

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

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.

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.

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

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 the promotion of international integration and the referencing of countries.

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

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

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.

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

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.

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 Cominaty RTU intramuscular injection and Spikevax intramuscular injection.

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

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

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

Approval regarding treatment for COVID-19 with the drug Actemra intravenous infusion. Today, approval was granted for the addition of indications and effects related to COVID-19 for the pharmaceutical product Actemra intravenous infusion.

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

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.

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.

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

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.

Explanation of efforts toward international harmonization and reference country designation, issues related to program medical devices, and expectations for work style reform and utilization of IT systems.

Exchange of opinions on work style reform and promotion of digitization due to the novel coronavirus infection, awareness of program medical devices, and promotion of international cooperation.

Description of proposals and exchange of opinions regarding challenges in the regulatory environment for medical devices, work style reform, promotion of digitalization, and advancement of medical device development.

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.

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.

Opinions and recommendations on accelerating digitalization, international harmonization, promotion of clinical research, electronic labeling, UDI promotion, and international expansion strategies.

Recommendations and requests regarding streamlining regulations, work style reform, promotion of medical device development, cybersecurity, improvement of certification systems, and strengthening of medical safety measures.

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

A report has been received that certain lots of the COVID-19 Vaccine Moderna Intramuscular Injection (brand name: COVID-19 ワクチンモデルナ筋注) are being withheld from use. Multiple vaccination facilities reported foreign matter contamination in unused vaccine from specific lots. As a safety measure, in consultation with Takeda Pharmaceutical Company, the use of the following lots, where the risk of foreign matter contamination cannot be ruled out, has been suspended.

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

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

Fukui Prefecture provided information that Kobayashi Kako Co., Ltd. has begun voluntary recall of the following pharmaceutical product.

Notice of voluntary recall of pharmaceutical product (Class I)

Today, Osaka Prefecture provided information that Towa Yakuhin Co., Ltd. has begun voluntary recall of the following pharmaceutical product.

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.

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

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

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.

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

Products containing cannabis component THC

On December 3, 2019, voluntary recall initiated (Class I).

Zeria Shinyaku Kogyo Co., Ltd. has initiated a voluntary recall of the following pharmaceutical products, as reported by Tokyo.

On October 23, 2019 (Reiwa 1), voluntary recall initiated (Class I)

Shiga Prefecture provided information that Ohara Yakuhin Kogyo Co., Ltd. has initiated a voluntary recall of the pharmaceutical products listed in the attached document.

Notice of voluntary recall of pharmaceuticals (Class I)

Recall notice for pharmaceuticals (Class I)

Fukui Prefecture provided information that Kobayashi Kako Co., Ltd. has initiated a voluntary recall of the following pharmaceutical products.

Notice of voluntary recall of pharmaceuticals (Class I)

Recall of fraudulent Keshis (Somniferum variety)

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

Today, Tokyo Metropolitan Government provided information that Asuka Pharmaceutical Co., Ltd. has initiated a voluntary recall of the following pharmaceutical product, as detailed in the attached document.

A case has been reported where health damage occurred due to Indian-made oral abortion drugs imported privately via the internet. The Ministry of Health, Labour and Welfare has designated these Indian-made oral abortion drugs as specified products, restricting personal import unless confirmed by local health bureaus to be based on a physician's prescription. This designation applies to these drugs as well.

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.

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

The Ministry of Health, Labour and Welfare established the 'Designated Priority Review System' on April 1, 2015, to promote the development of innovative pharmaceuticals, medical devices, regenerative medicine products, and others, with the aim of facilitating their early practical use in Japan.

The Ministry of Health, Labour and Welfare established the 'Designated Priority Review System' on April 1, 2015, to promote the development of innovative pharmaceuticals, medical devices, regenerative medicine products, and others, with the aim of facilitating their early practical use in Japan.

The Ministry of Health, Labour and Welfare established the 'Designated Priority Review System' on April 1, 2015, to promote the development of innovative pharmaceuticals, medical devices, regenerative medicine products, etc., with the aim of facilitating their early practical use in Japan.

The Ministry of Health, Labour and Welfare established the 'Designated Fast-Track Review System' on April 1, 2015, to promote the development of innovative pharmaceuticals, medical devices, regenerative medicine products, etc., with the aim of accelerating their practical application in Japan.

The Ministry of Health, Labour and Welfare established the 'Designated Priority Review System' on April 1, 2015, to promote the development of innovative pharmaceuticals, medical devices, regenerative medicine products, etc., with the aim of facilitating their early practical use in Japan.

The Ministry of Health, Labour and Welfare established the 'Designated Priority Review System' on April 1, 2015, to promote the development of innovative pharmaceuticals, medical devices, regenerative medicine products, and others, with the aim of facilitating their early practical use in Japan.

The Ministry of Health, Labour and Welfare established the 'Designated Priority Review System' on April 1, 2015, to promote the development of innovative pharmaceuticals, medical devices, regenerative medicine products, etc., with the aim of early practical application in Japan.

The Ministry of Health, Labour and Welfare established the 'Designated Fast-Track Review System' on April 1, 2015, to promote the development of innovative pharmaceuticals, medical devices, regenerative medicine products, etc., with the aim of early practical application in Japan.

The Ministry of Health, Labour and Welfare established the 'Designated Fast-Track Review System' on April 1, 2015, to promote the development of innovative pharmaceuticals, medical devices, regenerative medicine products, etc., with the aim of early practical application in Japan.

The Ministry of Health, Labour and Welfare established the 'Designated Priority Review System' on April 1, 2015, to promote the development of innovative pharmaceuticals, medical devices, regenerative medicine products, and others, aiming for early practical application in Japan.

The Ministry of Health, Labour and Welfare established the 'Designated Priority Review System' on April 1, 2015, to promote the development of innovative pharmaceuticals, medical devices, regenerative medicine products, and others, with the aim of facilitating early practical application in Japan.

The Ministry of Health, Labour and Welfare established the 'Designated Priority Review System' on April 1, 2015, to promote the development of innovative pharmaceuticals, medical devices, regenerative medicine products, etc., with the aim of facilitating their early practical use in Japan.

The Ministry of Health, Labour and Welfare established the 'Designated Fast-Track Review System' on April 1, 2015, to promote the development of innovative pharmaceuticals, medical devices, regenerative medicine products, etc., with the aim of early practical application in Japan.

Results of the FY2015 'Unapproved and Unlicensed Pharmaceutical Purchase Survey' indicate that out of 146 health foods sold domestically with the aim of providing strengthening effects, two products were found to contain pharmaceutical ingredients (homotadalafil) upon analysis at the National Institute of Health Sciences.

Counterfeit products of the hepatitis B chronic liver disease treatment 'Vemlidy® Tablets 25mg' sold by Gilead Sciences, Inc. have been confirmed in China. The packaging (box) and product bottle labels are written in Japanese.

Listed the names of pharmaceuticals designated as target items under the Priority Review Designation System, along with their intended effects or efficacy and the applicant's name or organization.

Listing of pharmaceutical products designated as target items under the Designated Fast-Track Review System, including their names, intended effects or efficacy, and applicant names or designations.

Listed the names of pharmaceuticals designated as target items under the Accelerated Review Designation System, along with their intended effects or efficacy and the applicant's name or organization.

Listed the names of pharmaceuticals designated as target items under the Priority Review Designation System, along with their intended effects or efficacy and the applicant's name or organization.

Designated as an item subject to the 'Pioneering Review Designation System'.

Results of the 2014 Internet Sales Product Purchase Survey

Analysis of counterfeit products found at wholesale seller G in Tokyo indicated that they are tablets containing multiple types of vitamins.

Progress has been made in elucidating the distribution routes of counterfeit products. It has been confirmed that there are no cases of patients taking counterfeit products through the current distribution routes.

Nara Prefecture, Nara City, and Kyoto Prefecture conducted surveys of patients and their primary physicians to confirm the health status of all 62 patients who received and took the

The analysis results by Gilead Sciences' US headquarters and its external testing organizations are described, but there is no mention of violations or sanctions.

Notification issued regarding the discovery of counterfeit products at a pharmacy chain within Nara Prefecture to ensure proper pharmaceutical distribution.

Discovery of dangerous drugs containing specified substances

The Ministry of Health, Labour and Welfare issued an administrative disposition to the General Incorporated Foundation, Chemical and Serum Therapy Research Institute, on October 4, regarding manufacturing different from the description in the manufacturing and marketing approval for Enceback subcutaneous injection, and also provided an opportunity for explanation concerning an operational improvement order.

The Ministry of Health, Labour and Welfare has notified manufacturing and sales companies to understand the products in circulation and to submit approval applications for switching to alternative products within one year, and to conduct approval reviews promptly.

The Ministry of Health, Labour and Welfare conducted a review of the reported information. Today, at the Infectious Disease Subcommittee of the Health Science Council, based on the attached materials, the results of the review by the Ministry (which concluded there are no discrepancies that would significantly affect quality and safety), and the inventory outlook for similar products from other companies were reported. Opinions were sought on whether to approve the shipment of Kaken Pharmaceutical's 'Enceback Injection' (dry cell culture Japanese encephalitis vaccine). As a result, it was received that, from the perspective of promoting the prevention and control of Japanese encephalitis, shipment should be permitted to avoid supply shortages. Based on these opinions, the Ministry of Health, Labour and Welfare has decided to lift the request for Kaken Pharmaceutical's 'Enceback Injection' (dry cell culture Japanese encephalitis vaccine) to refrain from shipment as of today.