{"id":3800,"date":"2017-09-19T10:59:10","date_gmt":"2017-09-19T01:59:10","guid":{"rendered":"https:\/\/hcv1004zroqo.smartrelease.jp\/mg\/?page_id=3800"},"modified":"2017-10-13T14:04:59","modified_gmt":"2017-10-13T05:04:59","slug":"tomeisei_ippan","status":"publish","type":"page","link":"https:\/\/www.ominedo.co.jp\/en\/company\/transparency_guidelines\/tomeisei_ippan\/","title":{"rendered":"the Transparency guidelines (OTC medicines)"},"content":{"rendered":"<h2>Transparency guidelines for the relationship between company activities<br \/>\nand medical institutions, etc. (OTC medicines)<\/h2>\n<p>&nbsp;<\/p>\n<p>Ominedo Pharmaceutical Industry Co., Ltd. (hereinafter called \u201cthe Company\u201d) established the \u201cTransparency guidelines for the relationship between company activities and medical institutions, etc.<sup>1)<\/sup>\u201d as follows in order to ensure the transparency<br \/>\nof relationships with medical institutions, etc. in all stages from research and development of OTC medicines to the manufacture and sales of products and to obtain a broad understanding that our company\u2019s activities are conducted upon securing high ethical standards.<\/p>\n<p>&nbsp;<\/p>\n<h3>1. Method and timing of disclosure<\/h3>\n<p>\nThe Company will disclose via the Company website the funding that is to be disclosed<br \/>\nfor the target annual year (October to September) after the settlement is finalized.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h3>2. Target for disclosure<\/h3>\n<p>&nbsp;<\/p>\n<p>A. Research and development expenses, etc.<\/p>\n<p>A. Research and development expenses, etc.<br \/>\nOTC medicines, etc. include those for clinical studies performed under public regulations such as the GCP Ordinance <sup>2)<\/sup>,<br \/>\nclinical trials to develop medical medicines, and post\u2010marketing clinical studies. They also include expenses for adverse reaction\/infection reports, post\u2010marketing surveillance, etc. performed under public regulations such as the GPSP Ordinance <sup>3)<\/sup>, the GVP Ordinance <sup>4)<\/sup>, etc.<\/p>\n<p>\u30fbJoint research expenses \u3000\u3000\u3000\u3000\u3000\u3000\u3000       \u3000Total annual amount<\/p>\n<p>\u30fbOutsourcing research expenses \u3000\u3000\u3000\u3000\u3000\u3000 \u3000\u3000Total annual amount<\/p>\n<p>\u30fbClinical study expenses \u3000\u3000\u3000\u3000\u3000      \u3000 \u3000\u3000Total annual amount<\/p>\n<p>\u30fbPost-marketing clinical study expenses \u3000\u3000 \u3000Total annual amount<\/p>\n<p>\u30fbAdverse reaction\/infection report expenses  \u3000Total annual amount<\/p>\n<p>\u30fbPost-marketing surveillance expenses \u3000\u3000\u3000\u3000\u3000Total annual amount<\/p>\n<p>&nbsp;<\/p>\n<p>B. Grants for academic research<\/p>\n<p>\u3000Scholarship donations and general donations provided for academic research and<br \/>\nresearch grants, as well as donations to academic societies and co-sponsored expenses<br \/>\nas support for meetings held by academic societies, etc.<\/p>\n<p>\u30fbScholarship donation<sup>5)<\/sup> \u3000        \u3000XX University, XX class: XX cases, XX yen<\/p>\n<p>\u30fbGeneral donation<sup>6)<\/sup> \u3000\u3000            XX University (XX Foundation): XX cases, XX yen<\/p>\n<p>\u30fbDonation to academic society<sup>7)<\/sup> \u3000\u3000The XX Academic meeting (XX regional meeting\/XX<br \/>\nresearch meeting): XX yen<\/p>\n<p>\u30fbCo-sponsored expenses<sup>8)<\/sup> \u3000       \u3000The XX Academic meeting, XX seminar: XX yen<\/p>\n<p>&nbsp;<\/p>\n<p>C. Manuscript writing expenses, etc.<\/p>\n<p>Expenses for requests of lecture meetings and manuscript writing to provide scientific information, etc. on OTC medicines, etc. as well as those for consulting services.<\/p>\n<p>\u30fbExpense for lecture \u3000Professor XX (Director), Department of XX, XX University (XX<br \/>\nHospital): XX cases, XX yen<\/p>\n<p>\u30fbManuscript writing\/supervising expenses<sup>9)<\/sup> \u3000Professor XX (Director), Department of XX,<br \/>\nXX University (XX Hospital): XX cases, XX yen<\/p>\n<p>\u30fbExpense for consulting contracts<sup>10)<\/sup>         Professor XX (Hospital Director), Department of<br \/>\nXX, XX University (XX Hospital): XX cases, XX yen<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>D. Information provision\u2010related expenses<\/p>\n<p>Expenses of lectures and explanatory meetings necessary for providing scientific information on OTC medicines etc. to healthcare<br \/>\nprofessionals.<\/p>\n<p>\u30fbAnnual number of cases and annual total amount of lecture expenses<\/p>\n<p>\u30fbAnnual number of cases and annual total amount of explanatory meeting expenses<\/p>\n<p>\u30fbAnnual total amount of medical and pharmaceutical literature, etc. supply expenses<\/p>\n<p>&nbsp;<\/p>\n<p>E. Other expenses<\/p>\n<p>Expenses as a social ceremony to medical institutions,etc. related to research and development of OTC medicines etc.<\/p>\n<p>\u30fbAnnual total amount of expenses for hospitality, etc.<\/p>\n<p>&nbsp;<\/p>\n<p>End<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p> (Notes)<\/p>\n<p>1) Medical institutions, etc. indicates the following (1) to (4) in Japan.<\/p>\n<p>(1) Medical institutions\u2026Hospitals, clinics, nursing homes for the elderly, pharmacies,<br \/>\nother medical facilities and organizations.<\/p>\n<p>(2) Research institutions\u2026Research departments affiliated with medical institutions,<br \/>\nmedical and pharmaceutical departments in universities, and other life science research<br \/>\ndepartments.<\/p>\n<p>(3) Medical organizations\u2026Medical organizations\u2026 Medical associations,<br \/>\npharmaceutical associations, medical societies, pharmaceutical societies, other medical<br \/>\nand pharmaceutical organizations.<\/p>\n<p>(4) Healthcare professionals\u2026Medical professionals (doctors, dentists, pharmacists,<br \/>\npublic health nurses, nurses, persons involved in other medical and nursing jobs),<br \/>\nmedical staff (directors and workers in medical institutions other than medical<br \/>\nprofessionals, and other people in medical institutions involved in the selection and<br \/>\npurchase of OTC medicines), life science researchers in science and technology fields other<br \/>\nthan those in medical and pharmaceutical fields.<\/p>\n<p>&nbsp;<\/p>\n<p>2) GCP Ordinance\u2026Good Clinical Practice (GCP) Ordinance indicates the \u201cOrdinance<br \/>\non the standards for the implementation of clinical trials\u201d of the Ministry of Health,<br \/>\nLabor and Welfare.<\/p>\n<p>&nbsp;<\/p>\n<p>3) GPSP Ordinance\u2026Good Post-marketing Study Practice (GPSP) Ordinance<br \/>\nindicates the \u201cOrdinance on the Standards for the Implementation of Post-Marketing<br \/>\nSurveillance and Study\u201d of the Ministry of Health, Labor and Welfare.<\/p>\n<p>&nbsp;<\/p>\n<p>4) GVP Ordinance\u2026Good Vigilance Practice (GVP) Ordinance indicates the<br \/>\n\u201cOrdinance on Standards for Post-Marketing Safety Management for Medicines,<br \/>\nQuasi-Medicines, Cosmetics, and Medical Devices\u201d of the Ministry of Health, Labor and<br \/>\nWelfare.<\/p>\n<p>&nbsp;<\/p>\n<p>5) Scholarship donation\u2026A donation provided to research institutions such as<br \/>\nuniversities for to support academic research and research grants.<\/p>\n<p>&nbsp;<\/p>\n<p>6) General donation\u2026A donation provided to support the anniversary business and<br \/>\nother business operations of medical institutions, etc.<\/p>\n<p>&nbsp;<\/p>\n<p>7) Donation to academic society\u2026A donation provided to support meetings held by<br \/>\nan academic society, etc. and supports of other activities.<\/p>\n<p>&nbsp;<\/p>\n<p>8) Co-sponsored expenses\u2026Expenses including venue costs borne by the Company for<br \/>\nmeetings jointly held with an academic society, etc.<\/p>\n<p>&nbsp;<\/p>\n<p>9) Manuscript writing\/supervising expenses\u2026Expenses for manuscript writing and<br \/>\nsupervising of materials for the provision of medical and pharmaceutical information.<\/p>\n<p>&nbsp;<\/p>\n<p>10) Expense for consulting services\u2026An expense incurred when instruction, advice,<br \/>\netc. is received based on a contract with a medical institution, etc.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Transparency guidelines for the relationship between company activities and medical institutions, etc. (OTC medicines) &nbsp; Ominedo Pharmaceutical Industry Co., Ltd. (hereinafter called \u201cthe Company\u201d) established the \u201cTransparency guidelines for the relationship between company activities and medical institutions, etc.1)\u201d as follows in order to ensure the transparency of relationships with medical institutions, etc. in all stages from research and development of OTC medicines to the manufacture and sales of products and to obtain a broad understanding that our company\u2019s activities are conducted upon securing high ethical standards. &nbsp; 1. Method and timing of disclosure The Company will disclose via the Company website the funding that is to be disclosed for the [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":3789,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-3800","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.ominedo.co.jp\/en\/wp-json\/wp\/v2\/pages\/3800","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.ominedo.co.jp\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.ominedo.co.jp\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.ominedo.co.jp\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.ominedo.co.jp\/en\/wp-json\/wp\/v2\/comments?post=3800"}],"version-history":[{"count":5,"href":"https:\/\/www.ominedo.co.jp\/en\/wp-json\/wp\/v2\/pages\/3800\/revisions"}],"predecessor-version":[{"id":3962,"href":"https:\/\/www.ominedo.co.jp\/en\/wp-json\/wp\/v2\/pages\/3800\/revisions\/3962"}],"up":[{"embeddable":true,"href":"https:\/\/www.ominedo.co.jp\/en\/wp-json\/wp\/v2\/pages\/3789"}],"wp:attachment":[{"href":"https:\/\/www.ominedo.co.jp\/en\/wp-json\/wp\/v2\/media?parent=3800"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}