Strengthening of the inspection system assuming simultaneous epidemic with seasonal influenza this winter
The Ministry of Health, Labor and Welfare's New Coronavirus Infectious Disease Control Headquarters has requested to strengthen the inspection system in anticipation of a simultaneous epidemic with seasonal influenza this winter. In particular, pharmacies, etc. are required to develop a system so that antigen qualitative test kits can be purchased even on holidays when the infection spreads.
Please see the notice below for more information.
How to use oral antiviral drugs (Lagebrio® Capsules and Pakirobid® Packs) in facilities for the elderly, etc. (revised)
We have already shown how to use oral antiviral drugs for patients with COVID-19 in facilities for the elderly.
Regarding the oral antiviral drug “Monupiravi” (brand name: Lagebrio® Capsules 200mg), general distribution of this drug by the manufacturing and marketing authorization holder began on September 16th. Please note that the usage method is summarized as follows. There is no change in how Nilmatrelvir/ritonavir (brand name: Pakirovid® Pack) is used in facilities for the elderly.
Please see the notice below for more information.
Leaflet on appropriate selection of antigen qualitative test kit for new coronavirus infection
In light of the fact that general-use antigen qualitative test kits for novel coronavirus infections have been approved based on the Pharmaceutical Affairs Law and will be manufactured and sold, the information leaflet has been revised as attached. rice field.
We ask that you once again make it known that consumers should choose antigen qualitative test kits for medical use or general use that have been approved based on the Pharmaceuticals and Medical Devices Law, rather than antigen qualitative test kits for research use.
Please see the notice below for more information.
Regarding the handling of the expiration date of the pachyvid pack
The shelf life of pakilobid packs (ingredient names nilmatrelvir, ritonavir) has been extended from 12 months to 18 months.
The handling of the notification below applies to preparations that comply with the storage method on the package insert.
Please see the notice below for more information.
About the handling of the expiration date of the Pako bid pack (PDF: 130KB)
Handling of expiry date of Xebdy Drip Infusion 500mg
The shelf life of Zebudy Intravenous Infusion 500mg (ingredient name: sotrovimab (genetical recombination)) has been extended from 18 months to 24 months.
In addition, along with this, "Handling of expiry date of Zebudy intravenous drip 500 mg" (January 21, 2020, Ministry of Health, Labor and Welfare Promotion Headquarters administrative contact) will be abolished and replaced with this administrative contact.
The handling of the notification below applies to preparations that comply with the storage method on the package insert.
Please see the notice below for more information.
Handling of expiry date of Xebdy Drip Infusion 500mg (PDF: 102KB)
Handling of the expiry date of Lagebrio Capsules 200mg
The shelf life of Lagebrio Capsules 200mg (ingredient name: Mornupilavi) has been extended from 24 months to 30 months.
The handling of the notification below applies to preparations that comply with the storage method on the package insert.
Please see the notice below for more information.
Regarding the handling of the expiry date of Lagebrio Capsules 200mg (PDF: 106KB)
Points to note when selling general-purpose new coronavirus antigen qualitative test kits under the epidemic of new coronavirus infectious disease
Regarding the general-purpose antigen qualitative test kit (hereinafter referred to as "antigen test kit (OTC) Law No. 145 of 1935.) Based on the approval of Article 23-2-5, Paragraph 1, it was decided to manufacture and sell the antigen test kit (OTC). It has been arranged according to the notice below.
Please see the notice below for more information.
Regarding the handling of general-use novel coronavirus antigen qualitative test kits during the manufacturing and sales period under the epidemic of new coronavirus infectious diseases
Currently, with the spread of the new coronavirus infection, the demand for medical antigen qualitative test kits (hereinafter referred to as “medical antigen test kits”) related to the new coronavirus infection, which is an in-vitro diagnostic drug, is increasing. increase. Domestic manufacturers and distributors are striving to increase production as much as possible to strengthen supply. In order to strengthen the system for self-testing as a self-check in situations where you are concerned about infection, and to prevent the spread of infection, the "Handling of application for manufacturing and marketing approval for general-use novel coronavirus antigen qualitative test kits" (Reiwa PSEHB Notification No. 0817-2 issued on August 17, 2004 by the Director of the Medical Device Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labor and Welfare) Attachment "Guidelines for general-use test reagents for general-use SARS coronavirus antigen kits" have been formulated. Based on the above, it is expected that a medical antigen test kit for novel coronavirus infection (hereinafter referred to as "antigen test kit for general use") will be approved as an over-the-counter drug. Therefore, we have decided to notify the following regarding the handling of the manufacturing and marketing of non-prescription antigen test kits by a marketing authorization holder who has obtained manufacturing and marketing approval for both medical and non-prescription antigen test kits. Please inform the concerned parties under your control.
Please note that the handling of the following notifications is a temporary and exceptional response in light of the increasing number of people infected with the new coronavirus, and the handling will be changed or abolished based on changes in the epidemic situation in the future. If you do, the Ministry of Health, Labor and Welfare will contact you to that effect, so please be aware.
Please see the notice below for more information.
Supervising guidance and points to note regarding sales of antigen qualitative test kits for research on new coronavirus infectious disease
Of the test kits that measure the presence or absence of novel coronavirus antigens, we have just indicated the handling of products that are not intended for diagnosis and are intended for research use (hereinafter referred to as "research antigen qualitative test kits").
Based on the situation after the issuance of the administrative notice, we have organized the points to consider regarding the sales of research antigen qualitative test kits as follows. In addition, it is as if it is an in vitro diagnostic drug that has been approved based on the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices (Law No. 145 of 1960, hereinafter referred to as the "Pharmaceutical Machinery Law"). Anything that gives false recognition will be subject to guidance and control as per the notice below.
Please see the notice below for more information.
Points to note regarding antigen qualitative test kits for research on novel coronavirus infections (Part 2)
So far, we have shown how to handle antigen qualitative test kits for research on novel coronavirus infections.
Recently, it was reported that a certain company would provide free antigen qualitative test kits for research use to local governments nationwide that requested them. Please take note. In addition, please make it known again that consumers should choose antigen qualitative test kits for medical use that have been approved based on the Pharmaceutical Affairs Law, rather than antigen qualitative test kits for research use.
Please see the notice below for more information.
Q&A regarding "handling of medical antigen qualitative test kits at pharmacies during the epidemic of new coronavirus infection"
As a special response to the new coronavirus infection, please refer to "Handling of medical antigen qualitative test kits at pharmacies during the outbreak of the new coronavirus infection" regarding points to note when selling medical antigen qualitative test kits at pharmacies. About” (office communication dated September 27, 2021 (partially revised on March 17, 2022)), etc.
Recently, we have provided a Q&A as an attachment regarding points to consider when selling a medical antigen qualitative test kit that uses saliva as a sample at pharmacies.
Please see the notice below for more information.
Notes on sales of antigen qualitative test kits for research on coronavirus infectious diseases
In the "Regarding monitoring guidance and points to note regarding the sale of antigen qualitative test kits for research on new coronavirus infectious diseases" (administrative communication dated December 22, 2021), test kits that measure the presence or absence of new coronavirus antigens Of these, the handling of products that are not intended for diagnostic purposes and are intended for research purposes (hereinafter referred to as "antigen qualitative test kits for research") has been indicated.
Based on the situation after the issuance of the administrative notice, we have organized the points to consider regarding the sales of research antigen qualitative test kits as follows.
Please see the notice below for more information.
About handling of medical antigen qualitative test kits at pharmacies under the epidemic of new coronavirus infection
Medical Antigen Qualitative Test Kit for Novel Coronavirus Infectious Diseases (Act on Securing Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices (Law No. 145 of 1960; hereinafter referred to as “Pharmaceutical Machinery Law”) ) is expected to be used in medical institutions, etc., but as a special response to the new coronavirus infection, medical antigen qualitative test kits are being sold at pharmacies. We would like to inform you that we have organized the points to note in doing so as shown in the notice below.
Please see the notice below for more information.
About drug delivery support business for patients such as home medical treatment at pharmacies accompanying the implementation of medication guidance using telephones and information communication devices
Regarding medication guidance by telephone and information communication equipment, please refer to "Temporary and exceptional handling of medical treatment using telephone and information communication equipment during the spread of new coronavirus infectious disease" (April 10, 2020) Date Ministry of Health, Labor and Welfare Health Policy Bureau Medical Affairs Division, Pharmaceutical and Environmental Health Bureau General Affairs Division Administrative Notice.Hereafter referred to as “April 10 Administrative Notice”.) We have decided to implement a drug delivery support project for patients undergoing home treatment (hereinafter referred to as the "support project").
In addition, pharmacies regularly grasp the implementation status of medication guidance, etc. by telephone and information communication devices at pharmacies, and are implemented based on "5. Verification within the response period by this administrative communication" of the April 10 administrative communication. In order to collect the necessary information for verification, we will report to each prefectural pharmacist association every month on the implementation status of medication guidance, etc. and drug delivery, etc., including those that are not eligible for support projects. Please.
Please see the notice below for more information.
Exceptions for drugs subject to special approval
Pursuant to the provisions of Article 75, Paragraphs 2 and 3 of the Ordinance for Enforcement of the Law Concerning Ensuring Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices (Government Ordinance No. 11 of 1961; hereinafter referred to as the "Cabinet Ordinance"), Since it is necessary to use it urgently, the immediate container, etc., should be placed in accordance with Article 50 of the Law Concerning Quality, Efficacy and Safety Assurance of Pharmaceuticals, Medical Devices, Etc. (Law No. 145 of 1960; and a public notice designating nilmatrelvir, ritonavir, and their preparations as drugs designated by the Minister of Health, Labor and Welfare as drugs for which it is recognized that there is no time to make descriptions, etc. pursuant to the provisions of Article 68-17 (drugs, medical devices, etc.) Partial revision of drugs designated by the Minister of Health, Labor and Welfare pursuant to the provisions of Article 75, paragraphs 2 and 3 of the Enforcement Order of the Act on Ensuring Quality, Efficacy and Safety (2020 Ministry of Health, Labor and Welfare) Notification No. 33)) was promulgated today and came into force on the same date.
Along with this, special provisions regarding drugs related to special approval will be applied to nilmatrelvir, ritonavir and their formulations as shown in the notification below.
Please see the notice below for more information.
Exceptions for pharmaceuticals subject to special approval (PDF: 104KB)
Handling of instruments for measuring blood oxygen saturation
In the past, mechanical devices that have the function of measuring blood oxygen saturation have been treated as medical devices in principle. However, in recent years, the use of blood oxygen saturation has progressed, and its use in exercise training has become widely known. I decided to show
Please see the notice below for more information.
Regarding the handling of instruments for measuring blood oxygen saturation (PDF: 119KB)
Posting information on approved and certified pulse oximeters
Among the approved and certified pulse oximeters, we would like to inform you that the items whose package inserts are published on the website of the Pharmaceuticals and Medical Devices Agency will be posted on the website of the Ministry of Health, Labor and Welfare.
Please see the notice below for more information.
Posting information on approved and certified pulse oximeters (PDF: 71KB)
About the "Appropriate Advertisement and Labeling Guidelines for Pulse Oximeters"
The Japan Electronics and Information Technology Industries Association submitted a report stating that it had created a "Proper Advertisement and Labeling Guideline for Pulse Oximeters."
Please see the notice below for more information.
About "appropriate advertisement, indication guideline of pulse oximeter" (PDF: 384KB)
Distribution of Oral Antiviral Drugs to Medical Institutions and Pharmacies in New Coronavirus Infections (Additions and Modifications to Attachments and Questions and Answers)
Regarding the oral antiviral drug "Molnupiravir" (brand name: Lagebrio® Capsules 200mg, hereinafter referred to as "Lagebrio") for patients with new coronavirus infection, the new coronavirus infection was confirmed on December 24, 2021. It has received special approval as a therapeutic agent for the disease.
We would like to inform you about the allocation and use of Lagebrio as attached.
In addition, we have created a Q&A collection as attached in the attachment.
Please see the notice below for more information.
Regarding the description of the case where the vial was contaminated with a foreign object
Regarding measures to be taken in the event that the new coronavirus vaccine is contaminated with foreign substances, please refer to "Responses to the case where the new coronavirus vaccine is contaminated with foreign substances" (Ministry of Health, Labor and Welfare Health Bureau dated September 2, 2021) Health Division Vaccination Office, Pharmaceutical and Environmental Health Bureau Pharmaceutical Safety Division, Pharmaceutical and Environmental Health Bureau Monitoring Guidance and Narcotics Control Division Office Contact), but the vial in the preamble contained a foreign object. Since the description of the case was insufficient, we will inform you again as follows.
Please see the notice below for more information.
About correspondence when there is foreign matter contamination in new coronavirus vaccine
Regarding the new coronavirus vaccine, since there were many contaminations in a specific lot, some lots have been suspended from August 26, 2021, and some vaccination venues have been suspended since August 26, 2021. However, foreign substances were found in the vials, etc., which were not used, and the vaccination site decided to suspend the vaccination of some lots.
In light of this situation, we have summarized the measures to be taken in the event that the new coronavirus vaccine is contaminated with foreign substances, as well as thoroughly checking for foreign substances before vaccination.
Please see the notice below for more information.
About correspondence when new coronavirus vaccine had foreign substance contamination (PDF: 121KB)
Regarding the handling of unapproved new corona vaccines at medical institutions
Regarding the title, this time, regarding the new corona vaccine that has not been approved by the Act on Securing the Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices, etc., for the purpose of selling or giving to others, There was a report about a suspected case of importing a product into the country in violation of the law and inoculating an applicant.
In response to this, in order not to inoculate unapproved vaccines that violate the Pharmaceuticals and Medical Devices Law at medical institutions, we have organized the points to be careful as follows.
Please see the notice below for more information.
Points to note regarding temporary and exceptional handling of medical care using telephones and information communication devices during the spread of new coronavirus infections (response at pharmacies)
Regarding the title, the period from April to June 2020 was verified at the "10th Review Meeting on the Review of Guidelines for Proper Implementation of Online Medical Treatment" held on August 6, 2020. In light of this, the Ministry of Health, Labor and Welfare, dated August 26, 2020, issued the ``Points to Note Regarding Temporary and Exceptional Handling of Medical Treatments Using Telephones and Information and Communication Equipment in the Case of the Spread of New Coronavirus Infectious Diseases.'' Medical Policy Bureau Medical Affairs Division Administrative Notice) has just been issued.
We have summarized the points to note regarding temporary and exceptional handling at pharmacies in the future as shown in the notification below.
Please see the notice below for more information.
About the implementation method of the training implementation outline pertaining to the health support pharmacy based on the response to the new coronavirus infectious disease
Regarding the title, in light of the recent situation regarding the new coronavirus infection, the training in the "Training implementation guidelines related to health support pharmacies" is as follows until the infection of the new coronavirus infection is over. I decided to handle it.
Please see the notice below for more information.
Training for registered sellers based on the response to the novel coronavirus infection
Regarding the title, as part of measures to prevent the spread of new coronavirus infections, we are calling attention to avoid situations where the so-called "three Cs (closed spaces, crowded places, close-contact settings)" overlap.
In light of these circumstances, we have decided to improve the qualifications of existing sales distributors as stipulated in the "Guidelines for External Training to Improve the Qualities of Registered Distributors" and "Article 12 of the Supplementary Provisions of the Act for Partial Revision of the Pharmaceutical Affairs Law." We have decided to handle training, etc. in "About" as follows.
Please see the notice below for more information.
Regarding reports of side effects of pharmaceuticals, etc. from medical personnel related to the new coronavirus infection (request for publicity)
Regarding the title, pharmaceuticals, etc. used for the treatment of patients infected with the new coronavirus (including those suspected of having the new coronavirus infection) from medical personnel, based on the outbreak situation of the new coronavirus infection. We have summarized the items we would like to request from medical personnel when reporting side effects, etc. due to
Please see the notice below for more information.
(Attachment 1) Reports on side effects and defects during the GW period (PDF: 152KB)
(Attachment 2) PMDA Administrative Notice (PDF: 232KB)
Regarding the delivery method of medicines to patients who are receiving medical treatment at home in the case of temporary and special treatment such as medical treatment using telephones and information communication devices during the spread of new coronavirus infectious diseases
Regarding the title, recently, "Temporary and exceptional handling of medical treatment using telephones and information communication devices during the spread of new coronavirus infections" (Medical Affairs Division, Health Policy Bureau, Ministry of Health, Labor and Welfare dated April 10, 2020 , Pharmaceutical and Environmental Health Bureau General Affairs Division administrative contact.Hereafter referred to as "April 10 administrative contact".・As an exceptional response, we have indicated the handling of medical examinations and medication guidance using telephones and information communication devices. In this regard, in April 10th administrative notice 3 (1), when delivering drugs to patients with mild symptoms of the new coronavirus infection who are recuperating at home or staying at a hotel, it is necessary to state that "the patient is infected with the new coronavirus pharmacies and delivery companies will know that the patient is mildly ill.” In this case, the points to note for pharmacies and delivery companies are summarized as follows.
Please see the notice below for more information.
Handling of pharmacies and drug sales businesses affected by the spread of new coronavirus infections
Regarding the title, if further emergency measures are taken based on the declaration of a state of emergency in the future, pharmacists or registered sellers (hereinafter referred to as "pharmacists, etc.") will respond to telework, refrain from commuting, and take vacations. Acquisition, etc. may make it difficult to secure the necessary personnel at pharmacies or stores of drug distributors (hereinafter referred to as "pharmacies, etc.").
Even in such cases, in order to ensure the necessary medical care and drug delivery systems in each region, the Act on Securing the Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices (Act No. 145 of 1960) and Regarding the handling of the Enforcement Regulations for the Act on Ensuring Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices (Ministry of Health and Welfare Ordinance No. 1 of 1961), etc. Matters that are considered necessary to be made known to prefectures, etc. have been compiled as shown in the notice below.
Please see the notice below for more information.
Temporary and exceptional handling of medical care using telephones and information communication equipment during the spread of new coronavirus infections
Regarding the title, the "Emergency Economic Measures for Novel Coronavirus Infection" (approved by the Cabinet on April 7, 2020) states, "In the situation where the novel coronavirus infectious disease is rapidly expanding, In order to prevent infection, including infection prevention, as an emergency response, we will immediately review the system so that it can be used by patients who want online/telephone medical treatment and online/telephone medication guidance, and implement it as soon as possible.” am. Based on this, as a temporary and exceptional response in light of the spread of the new coronavirus infection and the difficulty of visiting medical institutions, medical treatment using telephones and information communication devices and medication guidance etc. We have summarized the handling as follows.
Please see the notice below for more information.
Regarding the handling of medical care and prescriptions using telephones and information communication equipment in the event of an increase in patients with new coronavirus infectious diseases
Regarding the title, cases where it is necessary to send prescription information by facsimile, etc. through medical treatment using telephones and information communication devices when patients, etc. who receive regular medical care with chronic diseases, etc. require continuous medical care and medication. Therefore, we have summarized the points to keep in mind regarding its handling in the appendix in advance.
Please see the notice below for more information.
Frequently Asked Questions
Especially frequently asked questions
Please use "Frequently Asked Questions".
Adobe Acrobat Reader is required to view PDF format files. If you do not have Adobe Acrobat Reader, please download it for free from the link in the banner.
inquiry
Affiliation: Minato Public Health Center Sanitation Division Medical Affairs and Pharmaceutical Affairs Section
Phone number: 03-6400-0044
Fax number: 03-3455-4470