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Over 300 “Crowdfunds” per year Super-selling producers are hard-working people who once crushed the company

 
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    Effect Efficacy

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    Act on ensuring the quality, effectiveness and safety of pharmaceuticals, medical equipment, etc.

    Act on ensuring the quality, effectiveness and safety of pharmaceuticals, medical equipment, etc.(No.English: Pharmaceutical Affairs Law) IsJapanInMedicine,Quasi-drug,Cosmetics,Medical equipmentas well as the Regenerative medicineEtc. Established operations related to productslaw.Law numberIs Law No. 35 of 145, on July 1960, 35 (Showa 8).AnnounceWas done.Pharmaceuticals and medical devices law,Drug machine methodIs abbreviated.

    The title at the time of enactment was "Pharmaceutical Affairs Law(Yakujiho), but it was changed to the current title by the enforcement of the law (26 Law No. 11) that partially amends the Pharmaceutical Affairs Law, etc. on November 25, 25.

    The purpose is to "regulate necessary measures to ensure the quality, effectiveness and safety of products such as pharmaceuticals, quasi-drugs, cosmetics, medical devices and regenerative medicine, and medical products with a particularly high need for medical treatment. And of medical equipmentResearch and DevelopmentBy taking necessary measures to promote health and hygiene, "(Article 1).Based on this purpose, it is stipulated that the product should not be manufactured, imported, or dispensed for pharmaceuticals, quasi-drugs, cosmetics, and medical devices without the approval, confirmation, permission, and supervision of the government.

    Definition

    Pharmaceuticals (Article 2)

    • Japanese PharmacopoeiaListed items
    • Products for the purpose of diagnosis, treatment or prevention of human or animal diseases, which are not products such as machinery / equipment, quasi-drugs, regenerative medicine, etc.
    • Products that are intended to affect the structure and function of humans or animals and are not products such as machinery / equipment, quasi-drugs, cosmetics, regenerative medicine, etc.

    poison

    poisonIs a kind of medicine.The definition and handling are stipulated in Article 44 and below of the law.

    Drugs with high toxicityPharmaceutical Affairs and Food Sanitation CouncilThe Minister of Health, Labor and Welfare designates it as a poisonous drug by law.The poison must have a white frame and white letters on a black background, and the product name and the letters "poison" must be written on it.In addition, when storing it, it must be stored and displayed in a lockable place separately from other items.

    In particular,Acute toxicityThe lethal dose (half lethal dose, LD50. The amount at which half die when that amount is administered. The same definition applies to "drugs" described later) is 1 mg or less per 50 kg of body weight by oral administration.

    Poisonous and Deleterious Substances Control LawDefined bypoisonOften confused with, but a completely different definition.According to Article 2 of the Poisonous and Deleterious Substances Control Law, poisonous drugs as pharmaceuticals are not poisonous substances.Non-medicinal poisons"Medicinal toxicants"Is displayed.Toxic drugs defined in this law are just one of the categories of medicines, and are used for the treatment and examination of diseases, and like other medicines, they are safe and useful medicines when used properly.

    As an exampleDigitoxin(Cardiotonic),hydrochloric acidmorphineEnd (narcotic)Analgesics),Amphotericin B(Antifungal drug) Such

    Powerful drug

    A powerful drug is a kind of medicine.The definition and handling are stipulated in Article 44 and below of the law.

    The Minister of Health, Labor and Welfare designates a highly dramatic drug as a powerful drug after hearing the opinion of the Pharmaceutical Affairs and Food Sanitation Council.The powerful drug must have a red frame and red letters on a white background, and the product name and the characters of "drama" must be written.In addition, when storing it, it must be stored and displayed separately from other items.

    Specifically, the lethal dose is 1 mg or less per 300 kg of body weight by oral administration and 1 mg or less per 200 kg of body weight by subcutaneous injection.

    Like the poisons mentioned above, it is defined by the Poisonous and Deleterious Substances Control Law.Deleterious substanceIt is a different definition from.According to Article 2 of the Poisonous and Deleterious Substances Control Law, powerful drugs as pharmaceuticals are not deleterious substances.Non-medicinal deleterious substances"Non-medicinal deleterious substance"Is displayed.howeverDichlorvosAlthough the same active ingredient may be divided into a powerful drug and a deleterious substance depending on the form of the drug, the same formulation is not designated as both a powerful drug and a deleterious substance.

    As an example,Halothane(Inhalation anesthetic), Tolbutamide (Oral diabetes drug), MostPsychotropic drugsな ど

    Ordinary medicine

    It is a drug other than poisonous and powerful drugs, and there is no specific agreement on labeling or storage method.  aspirin(Antipyretic analgesic),Furosemide(Diuretic)Such

    Addictive medicine

    Addictive medicineHas been designated by Article 1961, Item 50 of the Old Pharmaceutical Affairs Law since 9.internationalSleeping pillsIt is a drug that has been decided to be a prescription drug due to abuse of[1].. laterNarcotics and Psychotropic Drugs Control ActWill be added.

    Quasi-drug

    Quasi-drugIs defined by Article 2, Paragraph 2 of the same law.It has a mild effect on the human body and can be sold at general retail stores without the need for a license from a sales business unlike pharmaceutical products.

    • Quasi-drugs specified in Article 2
      Those used for the following purposes, which do not have the efficacy of pharmaceutical products and are not machinery or equipment.
      1. Nausea or other discomfort orBad breathOrbody odorPrevention (mouth refreshing agent (RentanEtc.), axillary odor inhibitor, antiperspirant)
      2. Prevention of heat rash and sores (talcum powderKind)
      3. Prevention of hair loss, hair growth or hair removal (Hair restorer・ Hair restorer, depilatory)
      4. It is used for the purpose of controlling rats, flies, mosquitoes, and other similar organisms for the health of humans or animals, and has no medicinal effects and is not machinery or equipment. ((Insecticide,Rodenticide, Insect repellent)
    • Minister of Health, Labour and WelfareQuasi-drugs designated by
      1. Sanitary cotton (including paper cotton) (Sanitary napkin, Clean cotton)
      2. Hair dye (including depigmenting agent and depigmenting agent)
      3. permanent・ Wave agent
      4. Cosmeceuticals (Medicated石 鹸Kind, medicateddentifriceKind, etc.)
      5. Bathing agent
      6. 11 Newly designated quasi-drugs (shifted from pharmaceuticals to quasi-drugs due to deregulation measures in 1999): Stomach refreshing agent, nourishing tonic / nutritional supplement, wound disinfection protective material / skin disinfectant ,vitaminOrcalciumReplenisher, throat refresher, cracks /RhagadesAgent,Heat rash・ Sore agent,Uonome・ Octopus agent, bulky agent ・ That agent
      7. 16 New range Quasi-drugs (Transition from pharmaceuticals to quasi-drugs due to deregulation measures in 2004):snorePreventive medicine, calcium-containing health medicine,GarglingMedicines, stomachic medicines, oropharyngeal medicines, contact lens wearing medicines, antiseptic medicines,ChilblainsMedications, laxatives, digestives, herbal medicines, health medicines,Intestinal medicine, Nasal congestion improving drug (external drug only), Vitamin-containing health drug
      8. In addition, softwarecontact lensThere are antiseptic agents (shifted from pharmaceuticals to quasi-drugs due to deregulation measures in 1995).

    Cosmetics

    CosmeticsIs defined in Article 2 of the same law.

    A substance that is rubbed or sprayed on the skin or hair to cleanse, beautify, increase the attractiveness, change the appearance, or keep the skin or hair healthy, and has a mild effect on the human body (quasi-drug). , Excluding those with the effects of quasi-drugs)

    Medical equipment

    Medical equipmentIs defined in Article 2 of the same law.

    Machinery and equipment (excluding products such as regenerative medicine) that are intended to affect the structure and function of humans or animals for the purpose of diagnosing, treating or preventing diseases of humans or animals, and are specified by Cabinet Order.

    Even if it's a standalone software, not a machine toolHealth softwareThe software called is treated as a medical device.Health software is a disease diagnosis program, a disease treatment program, a disease prevention program, and a recording medium on which they are recorded.Among them, those that may affect human life and health in the event of side effects or functional disorders are regulated for manufacture and sale in the same way as other medical devices (Article 23-2 relationship, Article 39 relations).If these are provided through a telecommunication line, they will be treated as a medical device sales business.

    Other definitions

    Biological products (Article 2, Paragraph 10)
    Those that are derived from humans or organisms (other than plants) and are designated by listening to the opinions of the Pharmaceutical Affairs and Food Sanitation Council as those that require special attention in terms of health and hygiene.
    Products derived from specific organisms (Article 2, Paragraph 11)
    Among biological products, those that require measures to prevent the occurrence or spread of harm and are designated after hearing the opinions of the Pharmaceutical Affairs and Food Sanitation Council.[Annotation 1]
    pharmacy(Article 2)
    pharmacist DispensingThe place where you do business.
    Designated drug (Article 2, Paragraph 15)
    Items that are highly probable to have central nervous system excitement or suppression or hallucinatory effects, and that may cause health hazards when used on the human body (Cannabis Control LawStipulate inmarijuana,Stimulants Control LawStipulate inStimulant,Narcotics and Psychotropic Drugs Control ActStipulate indrugas well as the Psychotropic drugsAndOpium lawStipulate inOpiumAnd the Minister of Health, Labor and WelfarePharmaceutical Affairs and Food Sanitation CouncilWhat to specify by listening to the opinion of.So-calledIllegal drug.
    Orphan drug・ Medical equipment for rare diseases (Article 2, Paragraph 16)
    Pharmaceuticals or medical devices used for orphan drugs specified in Article 77-2, Paragraph 1 of the same law.
    Clinical trial(Article 2)
    Of the materials to be submitted when applying for approval of drugs, etc., this is a test for the purpose of collecting materials related to the test results of clinical trials.

    Handling of pharmaceuticals, quasi-drugs, cosmetics, and medical devices

    Attachment

    As a general rule, pharmaceutical products and medical devices must be accompanied by documents containing warnings, contraindications, prohibitions, precautions, item specifications, operating methods, packaging units, etc.this"Attachment'That.

    display

    For pharmaceutical products, quasi-drugs, cosmetics, and medical devices, the name or address of the manufacturer or distributor, the name, serial number, or manufacturing code, etc., are required by law in the container, packaging, or direct encapsulation. Is obliged to describe.

    Advertising regulation

    No false or exaggerated articles may be advertised, described or disseminated with respect to pharmaceuticals, quasi-drugs, cosmetics or medical devices (Article 66).As a specific standard, there is an appropriate advertising standard for pharmaceutical products (September 29, 9, Yakusei 29 No. 0929 Notification of Director General of Pharmaceutical and Living Hygiene Bureau, Ministry of Health, Labor and Welfare). For required drugs, etc., it is not possible to advocate efficacy, etc. beyond the scope of approval or certification.

    Providing information and guidance regarding dispensed drugs, etc.

    The pharmacist must have the pharmacist provide the necessary information in writing and provide guidance based on the necessary pharmaceutical knowledge.The pharmacy operator must have the pharmacist confirm the age of the person who intends to use the drug, the status of use of other drugs or drugs, and other matters specified by the Ordinance of the Ministry of Health, Labor and Welfare.The pharmacy operator shall not sell or give the drug if it is not possible to provide or give guidance on the above-mentioned information, or if it is deemed that the proper use of the prescribed drug cannot be ensured. (Article 9)

    Licensing

    Authorization

    A permit is required to manufacture, sell, or sell certain items.

    • Cosmetics manufacturing and sales license
    • Pharmaceutical manufacturing and sales license (Types 1 to 3)
    • Quasi-drug manufacturing and sales license
    • Medical device manufacturing and salesPermission (Types 1 to 3)
    • Cosmetics manufacturing license
    • Pharmaceutical manufacturing license
    • Quasi-drug manufacturing license
    • Medical device manufacturing license
    • Highly managed medical device sales license

    Certification

    Manufacturing facilities outside Japan for pharmaceuticals, quasi-drugs, and medical devices marketed in Japan must obtain foreign manufacturer certification.

    Approval, etc.

    Pharmaceuticals and quasi-drugs marketed in JapanManufacturing and marketing approvalMust be obtained.For cosmetics, it is necessary to submit a manufacturing and sales notification.

    For medical devices, manufacturing and marketing approval must be obtained for highly controlled medical devices and managed medical devices other than designated managed medical devices, and manufacturing and marketing certification must be obtained for managed medical devices.For existing general medical devices with general names, it is necessary to submit a manufacturing and sales notification.

    Ministerial Ordinance

    Responsible person, manager

    • Responsible person (three roles) and responsible engineer
      • Manufacturing and sales business
        • General Manufacturing and Sales Manager
        • Quality Assurance Officer
        • Safety manager
      • Manufacturing industry, repair industry
    • Manager
      • Manufacturing manager (including veterinary drug manufacturing manager)
        Specified in GMP (QMS)
      • Sales manager of highly managed medical equipment sales business, rental business
      • Sales manager of managed medical equipment sales business and rental business
      • Pharmacy, general sales manager

    Qualifications/Licenses

    History and revision of the Pharmaceutical Affairs Law

    Pharmaceutical affairs regulations of each country

    footnote

    [How to use footnotes]

    注 釈

    1. ^ Blood products for transfusion do not form lots, that is, each one has slightly different properties, so there is a fundamental problem in trying to ensure its manufacture and shipment and safety under the Pharmaceutical Affairs Law, and in fact there are many safety reasons for that. There is a history of unnecessary disposal of various formulations.

    Source

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