Pharmaceutical practice information| Date | Notice number | Title |
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| December 9, 2020 | The yakuseiyakushinhatsu 1209 first | Reexamination results such as new pharmaceutical products
About 2020 (5) (PDF: 139KB) |
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| December 2, 2020 | yakuseiyakushinhatsu 1202 No. 5 | About some revisions of the most suitable use promotion guidelines on eborokumabu (genetic modification) preparation (PDF: 98KB) |
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| November 30, 2020 | Desk work contact | About pharmaceutical products appointed as instruction pharmaceutical products required (PDF: 102KB) |
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| November 27, 2020 | The yakuseiyakushinhatsu 1127 first | About some revisions of the most suitable use promotion guidelines on niborumabu (genetic modification) preparation (non-small-cell lung cancer, malignant melanoma, head and neck cancer, renal cell carcinoma, classic Hodgkin's lymphoma, stomach cancer, malignant pleural mesothelioma, high-frequency colon, rectal cancer having microsatellite instability (MSI-High) and cancer of the esophagus) (PDF: 8,177KB) |
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| November 24, 2020 | The yakuseiyakushinhatsu 1124 first | About some revisions of the most suitable use promotion guidelines on dupirumabu (genetic modification) preparation (atopic dermatitis, bronchial asthma, chronic sinusitis with nasal polypus) (PDF: 2,712KB) |
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| November 20, 2020 | The yakuseiyakushinhatsu 1120 first
The yakuseiyasuhatsu 1120 first | About notice matter on using serichinibu preparation (PDF: 151KB) |
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| November 19, 2020 | Medicine No. 2873 | About designation of governor-designated drug based on prevention of Kanagawa drug abuse regulations Article 10 Paragraph 1 (PDF: 812KB) |
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| November 19, 2020 | The first from medicine life 1119 | About revision of departmental order to set uses such as medical care to prescribe of four of drug to appoint to prescribe in law Article 2 Paragraph 15 and law Article 76 about quality, effective and safe securing of pharmaceutical products, medical equipment (PDF: 147KB) |
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| October 29, 2020 | The yakuseisohatsu 1029 first
The yakuseiyakushinhatsu 1029 first
The yakuseiyasuhatsu 1029 first
The yakuseikammahatsu 1029 first | About notice matter on using oxycodone hydrochloride hydrate slow-release preparation (PDF: 1,562KB) |
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| October 19, 2020 | Desk work contact | About results of healthy impact statement by use of metformin preparation that N-nitrosodimethylamine was detected (PDF: 3,617KB) |
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| October 19, 2020 | yakuseikammahatsu 1019 No. 2 | About 2019 "securing of generic medicine quality measures business" test result report (PDF: 2,436KB) |
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| October 7, 2020 | The yakuseisohatsu 1007 first
yakuseiyasuhatsu 1007 No. 2 | About common knowledge of "drugstore hiyari hat example collection, analysis business 23rd report" and "annual report in drugstore hiyari hat example collection, analysis business 2019" (PDF: 90KB) |
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| October 7, 2020 | The yakuseikishinhatsu 1007 first
The yakuseiyasuhatsu 1007 first | About reporting for gel filling artificial milk bunch and skin dilatant shrubbery patient (PDF: 217KB) |
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| October 6, 2020 | The first from medicine life 1006 | About the enforcement of departmental order to revise a part of drug and the psychotropic drug control method enforcement regulations (PDF: 566KB) |
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| September 29, 2020 | The yakuseifukuhatsu 0929 first | About common knowledge of intensive public information about health hazard relief system that incorporated administrative agency Pharmaceuticals and Medical Devices Agency enforces (PDF: 5,308KB) |
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| September 25, 2020 | yakuseiyakushinhatsu 0925 No. 17 | About making of the most suitable use promotion guidelines on atezorizumabu (genetic modification) preparation (hepatocellular carcinoma) and some revisions of the most suitable use promotion guidelines on atezorizumabu (genetic modification) preparation (non-small-cell lung cancer, small cell lung cancer, breast cancer) (PDF: 4,327KB) |
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| September 25, 2020 | yakuseiyakushinhatsu 0925 No. 13 | About some revisions of the most suitable use promotion guidelines on niborumabu (genetic modification) preparation (non-small-cell lung cancer, malignant melanoma, head and neck cancer, renal cell carcinoma, classic Hodgkin's lymphoma, stomach cancer, malignant pleural mesothelioma, high-frequency colon, rectal cancer having microsatellite instability (MSI-High) and cancer of the esophagus) (PDF: 8,244KB) |
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| September 25, 2020 | yakuseiyakushinhatsu 0925 No. 8 | About notice matter on using raburizumabu (genetic modification) preparation (PDF: 1,041KB) |
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| September 25, 2020 | yakuseiyakushinhatsu 0925 No. 3
yakuseiyasuhatsu 0925 No. 2 | About notice matter on using pariperidomparumichin acid ester sustained-release suspension injection (12 weeks space intramuscular injection preparation) (PDF: 159KB) |
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| September 23, 2020 | The yakuseiyakushinhatsu 0923 first | Reexamination results such as new pharmaceutical products
About 2020 (4) (PDF: 117KB) |
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| September 23, 2020 | Medicine No. 2414 | About the conduct point to affect approval application material compatibility document investigation of product such as regenerative medicine, GCP on-the-spot surveys of product such as regenerative medicine and GPSP on-the-spot surveys of product such as regenerative medicine (PDF: 678KB) |
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| September 11, 2020 | Desk work contact | About "proposal for guidelines and affiliate for distributors for appropriate sale" of "pharmaceutical products which can cause abuse" (reporting) (PDF: 846KB) |
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| September 9, 2020 | yakuseiyakushinhatsu 0909 No. 2 | Reexamination results such as new pharmaceutical products
About 2020 (3) (PDF: 107KB) |
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| September 9, 2020 | Medicine No. 2320 | About the handling on attached documents such as approval with condition (PDF: 2,009KB) |
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| September 1, 2020 | Desk work contact | About results of healthy impact statement by use of ranitidine hydrochloride preparation that N-nitrosodimethylamine was detected or nizatidine preparation (PDF: 330KB) |
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| August 31, 2020 | Desk work contact | About document affecting clinical trial of medical equipment or record (PDF: 274KB) |
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| August 31, 2020 | yakuseikishinhatsu 0831 No. 13 | Of "products such as regenerative medicine about some revisions of departmental order about standard of conduct of clinical study" (PDF: 61KB) |
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| August 31, 2020 | yakuseikishinhatsu 0831 No. 12 | About some revisions about "guidance" of "departmental order about standard of conduct of clinical study of medical equipment" (PDF: 771KB) |
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| August 31, 2020 | yakuseikishinhatsu 0831 No. 11 | About points to keep in mind in report about report such as clinical trial malfunction to affect processing cells (PDF: 201KB) |
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| August 31, 2020 | yakuseikishinhatsu 0831 No. 10 | About points to keep in mind in report about report such as clinical trial malfunction to affect machine appliances for incorporated administrative agency Pharmaceuticals and Medical Devices Agency (PDF: 233KB) |
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| August 31, 2020 | From medicine life 0831 No. 9 | About reports such as clinical trial malfunction to affect machine appliances for incorporated administrative agency Pharmaceuticals and Medical Devices Agency (PDF: 269KB) |
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| August 31, 2020 | yakuseikishinhatsu 0831 No. 9 | About the handling of reports such as investigational plans to affect processing cells (PDF: 227KB) |
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| August 31, 2020 | From medicine life 0831 No. 7 | About reports such as investigational plans to affect processing cells (PDF: 129KB) |
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| August 31, 2020 | yakuseikishinhatsu 0831 No. 8 | About the handling of reports such as investigational plans to affect machine appliances (PDF: 268KB) |
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| August 31, 2020 | From medicine life 0831 No. 6 | About reports such as investigational plans to affect machine appliances (PDF: 185KB) |
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| August 31, 2020 | Desk work contact | About document affecting clinical trial or record (PDF: 188KB) |
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| August 31, 2020 | yakuseiyakushinhatsu 0831 No. 15 | About revision about "guidance" of "departmental order about standard of conduct of clinical study of pharmaceutical products" (PDF: 811KB) |
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| August 31, 2020 | yakuseiyakushinhatsu 0831 No. 13 | About reports such as clinical trial side effects of person who carried out clinical trial by oneself (PDF: 148KB) |
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| August 31, 2020 | yakuseiyakushinhatsu 0831 No. 11 | About the handling about notifications of investigational plan to affect drug by person who is going to carry out clinical trial by oneself (PDF: 185KB) |
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| August 31, 2020 | yakuseikammahatsu 0831 No. 6 | About the handling of notification about import confirmation accompanied with the enforcement of "law to revise parts such as laws about quality, effective and safe securing of pharmaceutical products, medical equipment" (PDF: 2,543KB) |
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| August 31, 2020 | yakuseisohatsu 0831 No. 6 | About notice matter on enforcing of law to revise parts such as laws about quality, effective and safe securing of pharmaceutical products, medical equipment (drugstore, pharmacist relations) (PDF: 99KB) |
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| August 31, 2020 | From medicine life 0831 No. 20 | About the promulgation of departmental order about maintenance of relations departmental order accompanied with the enforcement of law to revise such as laws about quality, effective and safe securing of pharmaceutical products, medical equipment (PDF: 312KB)
Official daily gazette (2020 Ministry of Health, Labour and Welfare ordinance No. 155) (PDF: 10,497KB) |
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| August 27, 2020 | Medicine No. 2200 | About designation of governor-designated drug based on prevention of Kanagawa drug abuse regulations Article 10 Paragraph 1 (PDF: 2,140KB) |
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| August 26, 2020 | The first from medicine life 0826 | About revision of departmental order to set uses such as medical care to prescribe of four of drug to appoint to prescribe in law Article 2 Paragraph 15 and law Article 76 about quality, effective and safe securing of pharmaceutical products, medical equipment (PDF: 151KB) |
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| August 25, 2020 | The yakuseikammahatsu 0825 first | About notice matter affecting changes of indication such as division of pharmaceutical products (PDF: 81KB) |
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| August 25, 2020 | The yakuseiyasuhatsu 0825 first | About some revisions about "list of division of OTC drug" (PDF: 491KB) |
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| August 21, 2020 | yakuseiyakushinhatsu 0821 No. 5 | About making of the most suitable use promotion guidelines on durubarumabu (genetic modification) preparation (small cell lung cancer) and some revisions of the most suitable use promotion guidelines on durubarumabu (genetic modification) preparation (non-small-cell lung cancer) (PDF: 2,370KB) |
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| August 21, 2020 | The yakuseiyakushinhatsu 0821 first | About making of the most suitable use promotion guidelines on pemuburorizumabu (genetic modification) preparation (cancer of the esophagus) and some revisions of the most suitable use promotion guidelines on pemuburorizumabu (genetic modification) preparation (non-small-cell lung cancer, malignant melanoma, classic Hodgkin's lymphoma, urinary tract epithelial cancer, high-frequency solid carcinoma, renal cell carcinoma having microsatellite instability (MSI-High) and head and neck cancer) (PDF: 7,655KB) |
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| August 17, 2020 | The yakuseiyakushinhatsu 0817 first
The yakuseiyasuhatsu 0817 first | About notice matter on using oshimeruchinibumeshiru acid salt preparation (PDF: 151KB) |
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| August 7, 2020 | Desk work contact | About issuance of generic medicine quality information (PDF: 71KB) |
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| August 7, 2020 | The yakuseiyasuhatsu 0807 first | About common knowledge of public information about report on adverse reactions to drugs from patient (request for cooperation) (PDF: 1,304KB) |
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| July 30, 2020 | The yakuseisohatsu 0730 first
yakuseiyakushinhatsu 0730 No. 9
The yakuseiyasuhatsu 0730 first
yakuseikammahatsu 0730 No. 10 | About extension of provisional measure period of modafinil preparation accompanied with influence of new coronavirus infectious disease (100 mg of modiodaru locks) (PDF: 150KB) |
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| July 28, 2020 | The first from medicine life 0728 | About the promulgation of cabinet ordinance about maintenance of relations cabinet ordinance accompanied with the enforcement of law to revise such as laws about quality, effective and safe securing of pharmaceutical products, medical equipment (PDF: 1,169KB) |
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| July 21, 2020 | The yakuseiyakushinhatsu 0721 first
The yakuseiyasuhatsu 0721 first | About notice matter in inoculation of particle vaccine (yeast origin) (sill guard 9 aqueous suspension intramuscular injection syringe) of recombinant sedimentation 9 values human papillomavirus used for the human papillomavirus infectious disease prevention (PDF: 102KB) |
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| July 8, 2020 | From medicine life 0708 No. 8 | About the promulgation of cabinet ordinance revising a part of the cabinet ordinance appointing stimulants raw material (notice) (PDF: 199KB) |
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| July 8, 2020 | From medicine life 0708 No. 5 | About the promulgation of cabinet ordinance revising a part of drug, drug raw materials plant, psychotropic drug and the cabinet ordinance appointing drug psychotropic drug raw materials (notice) (PDF: 360KB) |
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| June 29, 2020 | The yakuseiyakushinhatsu 0629 first | About notice matter on using parakeet botulinum toxin A preparation (PDF: 342KB) |
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| June 25, 2020 | yakuseiyakushinhatsu 0625 No. 9 | Reexamination results such as new pharmaceutical products
About 2020 (2) (PDF: 113KB) |
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| June 24, 2020 | The first from medicine life 0624 | About some revisions of poison and dynamite designation law (notice) (PDF: 539KB) |
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| June 18, 2020 | Medicine No. 1603 | About style when apply for publication newly to "exclusively used ingredient essence (raw materials) list as pharmaceutical products" or unless "profess itself to be pharmaceutic effect effect pharmaceutical products and ingredient essence (raw materials) list not to judge" (PDF: 599KB) |
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| June 10, 2020 | The yakuseiyakushinhatsu 0610 first | Reexamination results such as new pharmaceutical products
About 2020 (1) (PDF: 110KB) |
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| May 29, 2020 | The yakuseiyakushinhatsu 0529 first | About extension of reexamination period of new pharmaceutical products (PDF: 92KB) |
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| May 27, 2020 | The yakuseisohatsu 0527 first
yakuseiyakushinhatsu 0527 No. 5
The yakuseiyasuhatsu 0527 first
The yakuseikammahatsu 0527 first | About extension of provisional measure period of methylphenidate hydrochloride preparation accompanied with influence of new coronavirus infectious disease (18 mg of konsata locks, lock 27 mg and 36 mg of locks) (PDF: 146KB) |
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| May 12, 2020 | Medicine No. 1316 | About the regulations to revise a part of the prevention of Kanagawa drug abuse regulations (PDF: 888KB) |
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| May 8, 2020 | Desk work contact | About pharmaceutical products appointed as instruction pharmaceutical products required (PDF: 102KB) |
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| May 8, 2020 | The yakuseiyakushinhatsu 0508 first
The yakuseiyasuhatsu 0508 first
The yakuseikammahatsu 0508 first | About exception about pharmaceutical products affecting exception approval (PDF: 68KB) |
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| May 7, 2020 | yakuseiyakushinhatsu 0507 No. 12
The yakuseiyasuhatsu 0507 first | About notice matter on using rem decibuilding preparation (PDF: 129KB) |
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| May 7, 2020 | yakuseiyakushinhatsu 0507 No. 5 | About extension of validity of 150 mg of antiinfluenza virus medicine Rapiacta intravenous drip liquid vials (PDF: 102KB) |
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| May 7, 2020 | yakuseiyakushinhatsu 0507 No. 3 | About extension of validity of 20 mg of antiinfluenza virus medicine Inavir inhalation powdered drugs (PDF: 99KB) |
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| May 2, 2020 | The first from medicine life 0502 | About the enforcement of cabinet ordinance revising a part of the law enforcement order about quality, effective and safe securing of pharmaceutical products, medical equipment (PDF: 92KB) |
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| May 1, 2020 | Desk work contact | About reports such as side effects about pharmaceutical products from person concerned with medical care to affect new coronavirus infectious disease (PDF: 476KB) |
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| April 15, 2020 | The yakuseiyasuhatsu 0415 first | About some revisions about "list of division of OTC drug" (PDF: 229KB) |
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| April 10, 2020 | Desk work contact | About the handling about preservation of consent brief in clinical trial (PDF: 167KB) |
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| April 3, 2020 | yakuseikammahatsu 0403 No. 5 | About 2018 "securing of generic medicine quality measures business" test result report (PDF: 609KB) |
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| April 2, 2020 | yakuseisohatsu 0402 No. 2 | About public announcement of list of of pharmacist that composition of contraceptive is urgently available based on "guideline about appropriate conduct of online medical treatment" and drugstore (PDF: 221KB) |
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