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

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。

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.

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。

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

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

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

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.

新型コロナウイルスワクチンの特例承認について

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.

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

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

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。

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

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

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

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.

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.

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.

国際整合、リファレンスカントリー化、プログラム医療機器の課題、働き方改革、ITシステム活用についての取組と要望を説明。

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.

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 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.

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.

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.

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.

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

Notice of voluntary recall of pharmaceutical product (Class I)

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.

医薬品自主回収のお知らせ（クラスⅠ）

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.

薬と健康の週間の実施に協力・後援

薬と健康の週間の実施に協力・後援

Recall notice for pharmaceuticals (Class I)

Notice of voluntary recall of pharmaceuticals (Class I)

Notice of voluntary recall of pharmaceuticals (Class I)

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

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.

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

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.

「先駆け審査指定制度」の対象品目の募集を開始します

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.

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, 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, 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 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 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 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 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.

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.

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.

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.

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 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'.

心臓再同期療法の効果予測の判断を補助する医療機器プログラムである。

がん関連遺伝子の変異・増幅・融合を網羅的に検査するDNAシークエンサー診断システム。

気管欠損部位に留置し、気管の構造を保ち粘膜再建の足場となる点に新規性があり、画期性が高い。

パーキンソン病に対するiPS細胞由来のドパミン神経前駆細胞を用いた治療。

急性期（発症後18～36時間）の脳梗塞の治療を目的とした、ドナーの骨髄から採取して増殖させた成人接着性幹細胞に由来する幹細胞製品。

非自己iPS細胞由来ドパミン神経前駆細胞を用いたパーキンソン病治療であり、従来の治療法とは異なる作用機序を有する。

患者自身の口腔粘膜から採取した上皮細胞を培養した細胞シートであり、食道がんにおける広範囲内視鏡的粘膜下層剥離術（ESD）後の狭窄の抑制及び再上皮化までの日数の短縮目的とするものである。

ホウ素中性子捕捉療法（BNCT）に用いる中性子線を照射するための装置である。

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.

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

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

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

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 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.

It was found that reports to the Ministry of Health, Labour and Welfare were not properly made. Consequently, on September 18, 2015, a request was issued to refrain from shipment and to submit appropriate reports.

It was found that reports to the Ministry of Health, Labour and Welfare were not properly made. Consequently, on September 18, a request was issued to suspend shipments and to submit proper reports. Subsequently, the Ministry of Health, Labour and Welfare reviewed the reported information.

The Ministry of Health, Labour and Welfare evaluated 50 pharmaceutical products for which designation applications were submitted in August this year, and today designated six of these products as subject to the 'Pioneering Review Designation System' for the first time.

The Ministry of Health, Labour and Welfare evaluated 50 pharmaceutical products for which designation applications were submitted in August this year, and today designated six of these products as subject to the Priority Review System for the first time.

The Ministry of Health, Labour and Welfare evaluated 50 pharmaceutical products that received designated application approval in August this year and, as of today, designated six of these products as subject to the 'Pioneering Review Designation System' for the first time.

The Ministry of Health, Labour and Welfare evaluated 50 pharmaceutical products for which designation applications were submitted in August this year, and today designated six of these products as subject to the Pioneer Review Designation System for the first time.

The Ministry of Health, Labour and Welfare evaluated 50 pharmaceutical products for which designation applications were submitted in August this year, and today designated six of these products as subject to the Priority Review System for the first time.

The Ministry of Health, Labour and Welfare evaluated 50 pharmaceutical products for which designation applications were submitted in August this year, and today designated six of these products as subject to the Pioneer Approval System for the first time.

It was found that appropriate reports had not been made to the Ministry of Health, Labour and Welfare regarding discrepancies between the approval document and manufacturing practices. Consequently, on September 18, a request was made to suspend shipments and to submit proper reports. Subsequently, the Ministry of Health, Labour and Welfare reviewed the reported information.

It was found that the product was manufactured using a method different from the approved method. - Heparin was added without being listed in the approval document. - Additives were used in quantities different from those specified in the approval document. - Some steps in the manufacturing process described in the approval document were modified or omitted.