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The notice states that, under the relevant act, the Pharmacopoeia is revised effective from the notification date and sets out transitional measures for drugs listed in the previous and new Pharmacopoeia. It defines acceptance conditions for names and standards, outlines cutoff dates for conformity, and specifies rules for applying prior provisions.",{"@graph":69,"@context":127},[70,84,106],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":35,"@type":76,"position":81},"https://docshare.wps.com/document/healthcare/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/japanese-pharmacopoeia-supplementary-provisions-effective-date/295988/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/japanese-pharmacopoeia-supplementary-provisions-effective-date/295988.png","ImageObject",300,407,{"name":92,"@type":93},"River Wang","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-24","2026-09-18",true,{"@type":102,"interactionType":103,"userInteractionCount":105},"InteractionCounter",{"@type":104},"ViewAction",13,{"@type":107,"mainEntity":108},"FAQPage",[109,115,119,123],{"name":110,"@type":111,"acceptedAnswer":112},"What document is this English version based on?","Question",{"text":113,"@type":114},"It is the English version of the Japanese Pharmacopoeia, Eighteenth Edition, officially from June 7, 2021.","Answer",{"name":116,"@type":111,"acceptedAnswer":117},"What rule applies when there is a discrepancy between the Japanese original and the English translation?",{"text":118,"@type":114},"The Japanese original is authentic when any discrepancy arises.",{"name":120,"@type":111,"acceptedAnswer":121},"When do the Supplementary Provisions take effect?",{"text":122,"@type":114},"They apply from the date of the notification (the notification date as defined in Article 1).",{"name":124,"@type":111,"acceptedAnswer":125},"How long are transitional measures valid for conformity between old and new Pharmacopoeia listings?",{"text":126,"@type":114},"Transitional acceptance is provided through specified dates, including December 31, 2022 for certain cases and June 30, 2024 for additional conformity and prior-provision application.","https://schema.org",{"og:url":83,"og:type":129,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":131,"canonical":83},"index,follow",{"doc_id":133,"site_id":62},295988,1790217686,{"code":4,"msg":5,"data":136},{"doc_id":133,"user_id":137,"nickname":92,"user_avatar":138,"doc_module":4,"category_id":34,"category_name":35,"doc_title":65,"doc_description":67,"doc_content":139,"file_id":140,"file_url":141,"file_type":142,"file_size":143,"view_count":105,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":144,"language":145,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":146,"faqs":147,"seo_title":148,"seo_description":67,"update_tm":149,"read_time":150},1099514067438,"https://ap-avatar.wpscdn.com/avatar/100002539ee87300030?x-image-process=image/resize,m_fixed,w_180,h_180&k=1780474512215547542","JP XVIII  \nTHE JAPANESE PHARMACOPOEIA  \nEIGHTEENTH EDITION  \nOfficial from June 7, 2021  \nEnglish Version  \nTHE MINISTRY OF HEALTH, LABOUR AND WELFARE  \nNotice: This English Version of the Japanese Pharmacopoeia is published for the convenience of users unfamiliar with the Japanese language. When and if any discrepancy arises between the Japanese original and its English translation, the former is authentic.  \nThe Ministry of Health, Labour and Welfare Ministerial Notification No. 220  \nPursuant to Paragraph 1, Article 41 of Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Law No. 145, 1960), this notification stated that the Japanese Pharmacopoeia was revised as follows* .  \nTAMURA Norihisa  \nThe Minister of Health, Labour and Welfare  \nJune 7, 2021  \nJapanese Pharmacopoeia  \nPursuant to Paragraph 1, Article 41 of Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Law No. 145, 1960), the Japanese Pharmacopoeia was revised as follows.  \n(The text referred to by the term ``as follows'' are omitted here. All of the revised Japanese Pharmacopoeia in accordance with this notification are made available for public exhibition at the Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare, at each Regional Bureau of Health and Welfare, and at each Prefectural Office in Japan) .  \nSupplementary Provisions (Effective Date)  \nArticle 1 This Notification is applied from the date of the notification. (referred to as the ``notification date'' in the next and third articles)  \n(Transitional measures)  \nArticle 2 In the case of drugs which are listed in the Japanese Pharmacopoeia (hereinafter referred to as ``previous Pharmacopoeia'') and have been approved as of the notification date as prescribed under Paragraph 1, Article 14 of Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices [including drugs the Minister of Health, Labour and Welfare specifies (the Ministry of Health and Welfare Ministerial Notification No. 104, 1994) as of the day before the notification date as those exempted from marketing approval pursuant to Paragraph 1, Article 14 of the same law (hereinafter referred to as ``drugs exempted from approval'')], the Name and Standards established in the previous Pharmacopoeia (limited to part of the Name and Standards for the drugs concerned) may be accepted to conform to the Name and Standards established in the revised Japanese Pharmacopoeia (hereinafter referred to as ``new Pharmacopoeia'') (limited to part of the Name and Standards for the drugs concerned) in accordance with this notification before and on December 31, 2022 .  \nArticle 3 In the case of drugs which are listed in the new Pharmacopoeia (excluding those listed in the previous Pharmacopoeia) and have been approved as of the notification date as prescribed under the Paragraph 1, Article 14 of the same law (including those exempted from approval), they may be accepted as those being not listed in the new Pharmacopoeia before and on December 31, 2022 .  \nArticle 4 In the case of drugs which are listed in the new Pharmacopoeia, their commonly used names established in the previous Pharmacopoeia may be accepted to conform to the Name established in the new Pharmacopoeia before and on June 30, 2024 .  \nArticle 5 In the case of drugs which are listed in the new Pharmacopoeia, the previous provisions are applied before and on June 30, 2024, regardless of the Paragraph 34 of General Notices.  \n*The term ``as follows'' here indicates the contents of the Japanese Pharmacopoeia Eighteenth Edition from General Notice to Ultraviolet-Visible Reference Spectra (pp. 1 – 2587) .  \nCONTENTS  \nPreface............................................................i  \nThe Japanese Pharmacopoeia, Eighteenth Edition ...1  \nGeneral Notices .........................","cbCaiiEVcQhRGLhD","https://ap.wps.com/l/cbCaiiEVcQhRGLhD","pdf",5930309,420,"English","# Preface\n## Revision notice and Ministerial Notification\n## Supplementary Provisions (Effective Date)\n### Article 1 (Application from notification date)\n### Article 2–5 (Transitional measures and cutoff dates)","[{\"question\":\"What document is this English version based on?\",\"answer\":\"It is the English version of the Japanese Pharmacopoeia, Eighteenth Edition, officially from June 7, 2021.\"},{\"question\":\"What rule applies when there is a discrepancy between the Japanese original and the English translation?\",\"answer\":\"The Japanese original is authentic when any discrepancy arises.\"},{\"question\":\"When do the Supplementary Provisions take effect?\",\"answer\":\"They apply from the date of the notification (the notification date as defined in Article 1).\"},{\"question\":\"How long are transitional measures valid for conformity between old and new Pharmacopoeia listings?\",\"answer\":\"Transitional acceptance is provided through specified dates, including December 31, 2022 for certain cases and June 30, 2024 for additional conformity and prior-provision application.\"}]","Japanese Pharmacopoeia - Supplementary Provisions (Effective Date) | PDF",1789726617,1058]