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1. Licenses for Marketing and Manufacturing of pharmaceutical companyin japan

1) Licenses for marketing businesses:

Person wishing to start marketing business for drugs, quasi-drugs, cosmetics, or

medical devices must obtain a marketing business license of the prefecturalgovernor depending on the type of business !hese licenses are of the followingseven types

"1) !ype 1 drug marketing business license: #arketing of prescription drugs

"$) !ype $ drug marketing business license: #arketing of drugs other thanprescription drugs

"%) &uasi-drug marketing business license: #arketing of quasi-drugs

"') (osmetic drug marketing business license: #arketing of cosmetics

") !ype 1 medical device marketing business license: #arketing of speciallycontrolled medical devices

"*) !ype $ medical device marketing business license: #arketing of controlledmedical devices

"+) !ype % medical device marketing business license: #arketing of general medicaldevices

1.2 Good Manufacturing Practice (GMP): #P species that compliance withthe .egulations for /uildings 0 quipment of Pharmacies that specify standards forstructures and equipment in manufacturing plants for each an importantrequirement

1. !uality "tandards and Go#ernment $erti%cation:!he 2apanesePharmacopoeia, 2apanesePharmaceutical (ode3, 2apanesePharmaceutical3cipients, and other similarstandards have been specied as qualitystandards(ertain specied drugs such asbiological products must not be marketed orsupplied without government certicationbased on batch tests

1.& Good La'oratory Practice (GLP): LP species standards that must be metby testing facilities for nonclinical safety tests on drugs from the viewpoint of theequipment and management of the facilities

1. Good $linical Practice (G$P) 4(linical trials5 refer to studies with the

ob6ective of collecting data on clinical trialresults from among the data attached todrugapproval application forms

1. Good Post*marketing "tudy Practice (GP"P):!he P#7P ordinance wasenacted tospecify the system and scope of activities ofpharmaceutical companiesto assure properimplementation of post-marketingsurveillance of drugs

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1.+ Patent "ystem:!he patent term is $8 years from the timeof application as arule 9owever, to some e3tent the patent term can be e3tendedfor a ma3imum of years

1., -rug 'use $ontrol:2apan has enacted ve laws of its own: the arcotics andPsychotropics (ontrol Law, the ;pium Law, the (annabis (ontrol Law, the

7timulants (ontrol Law, and the Law (oncerning 7pecial Provisions for the arcoticsand Psychotropics (ontrol Law

2. /estricti#e ppro#al "ystem: !he restrictive approval system is applied tothe emergency drugs and those that prevent the spread of diseases that has severee

2.2ppro#al pplications for -rugs Manufactured 0#erseas: Pharmaceuticalmanufacturers outside2apan can apply directly under their ownname for marketingapproval if they performthe studies regarding quality, e?cacy, andsafety requiredfor the drugs they intend toe3port to 2apan 9ere the overseas manufacturerappoints a marketer in 2apan among those that have received a marketing businesslicense corresponding to approved product

. P3"3 P4/M$0P035 - 0643/ "6-/-":!he 2apanesePharmacopoeia "2P) was established and published to regulate the properties andqualities of drugs by the #9L> based the Pharmaceutical @

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assure their quality in institutions designatedby the #9L>, and the drugs cannotbe sold or otherwise marketed unless they pass these test

&. Pharmaceutical "uper#ision /ased on the provisions of thePharmaceutical@, prefectural governors, or other may appointCpharmaceutical inspectorsC in connection with the rationaliBation of pharmaceutical

manufacture, import, labeling, advertisements or marketing