المؤلفون: Takahashi H

المصدر: Yakushigaku zasshi [Yakushigaku Zasshi] 2016; Vol. 51 (1), pp. 29-39.

نوع المنشور: Historical Article; Journal Article

بيانات الدورية: Publisher: Nihon Yakushi Gakkai Country of Publication: Japan NLM ID: 1267223 Publication Model: Print Cited Medium: Print ISSN: 0285-2314 (Print) Linking ISSN: 02852314 NLM ISO Abbreviation: Yakushigaku Zasshi

مواضيع طبية MeSH: Product Surveillance, Postmarketing*, Drug and Narcotic Control/*history , Orphan Drug Production/*history, Drug-Related Side Effects and Adverse Reactions ; History, 20th Century ; Marketing ; Pharmacy ; Research

مستخلص: The present Pharmaceutical Affairs Law (PAL) was promulgated in October 1960 and enforced in February 1961．Thereafter, PAL has been frequently revised, was renamed the Pharmaceuticals and Medical Devices Act (PMD Act) in November 2013, and the PMD Act was enforced in November 2014. It describes the change of reference to Post-Marketing Surveillance (PMS) based on the sequence of revisions of PAL for approximately 50 years. Although the purpose of PAL in 1960 was “to control and regulate drugs, quasi-drugs, cosmetics and medical devices (drugs, etc.), and to contrive proper use,” it did not include rules regarding PMS. Thereafter, “to assure the quality, efficacy and safety of drugs, etc.,” “to promote research and development of orphan drugs, etc.” and “to regulate designated substances” were added to the purpose of PAL over a period of time. At the time of establishing the PMD Act, “to assure the quality, efficacy and safety of regenerative products, to promote their research and development, and to prevent the onset and spread of hazards to public health and hygiene through the use of drugs, etc. ”was added to the purpose. Simultaneously, the matters of control and regulation using PAL were increased whenever PAL was revised. Additionally, the PMS systems, such as adverse drug reactions reporting, drug reevaluation and drug reexamination, and the Good Post-Marketing Surveillance Practice (GPMSP) regarding the enforcement standards of PMS, etc. were initiated by regulatory directions and legislated after their establishment. Moreover, an infection reporting system and early-phase pharmcovigilance, etc. were added to the PMS systems. Furthermore, GPMSP was divided into the Good Vigilance Practice (GVP) for marketing license conditions and the Good Post-Marketing Study Practice (GPSP) for enforcement standards regarding post-marketing investigations and clinical trials, and both are regulated.

المؤلفون: Hattori A; Konishi Pharmaceutical Co., Ltd. 2-33-11 Kamiishikiri-machi, Higashi-Osaka, Osaka 579-8012.

المصدر: Yakushigaku zasshi [Yakushigaku Zasshi] 2011; Vol. 46 (2), pp. 73-7.

نوع المنشور: Historical Article; Journal Article

بيانات الدورية: Publisher: Nihon Yakushi Gakkai Country of Publication: Japan NLM ID: 1267223 Publication Model: Print Cited Medium: Print ISSN: 0285-2314 (Print) Linking ISSN: 02852314 NLM ISO Abbreviation: Yakushigaku Zasshi

مواضيع طبية MeSH: Camphor/*history , Insect Repellents/*history, Camphor/economics ; History, 19th Century ; History, 20th Century ; Insect Repellents/economics ; Japan ; Marketing

المؤلفون: Nishikawa T; The Japanese Society for History of Pharmacy, 2-4-41 Ebara, Shinagawa-ku, Tokyo 142-8501.

المصدر: Yakushigaku zasshi [Yakushigaku Zasshi] 2007; Vol. 42 (2), pp. 131-6.

نوع المنشور: Biography; Historical Article; Journal Article; Portrait

بيانات الدورية: Publisher: Nihon Yakushi Gakkai Country of Publication: Japan NLM ID: 1267223 Publication Model: Print Cited Medium: Print ISSN: 0285-2314 (Print) Linking ISSN: 02852314 NLM ISO Abbreviation: Yakushigaku Zasshi

مواضيع طبية MeSH: Drug Industry/*history, History, 20th Century ; Japan ; Marketing/history ; Pharmacists/history ; Propaganda

Personal Name as Subject: Ninomiya S

مستخلص: A Swiss pharmaceutical company (F-Hoffmann-La Roche Ltd.), first introduced the profession of "propagandist" in Japan in 1912. At the time, Shohei Ninomiya was a chief hospital pharmacist, but he changed his vocation to become the first "propah" (Japanese abbreviation for propagandist). The German physician Dr. Rudolf Ebering initiated Dr. Ninomiya in the methods and principles of "propah," and he faithfully practiced them. The defining principle of a modern European propagandist is one who is far from sales-centered. From the late 1970s through 1980s, however, Japanese pharmaceutical companies indulged in pursuing sales and neglected this principle, resulting in numerous abuses and adverse effects. Today, use of the description "medical representative" (MR) is more common than "propah." Even with this different description, pharmaceutical companies and MRs should never neglect the founding principle to avoid repeating such abuses.

المؤلفون: Hattori A

المصدر: Yakushigaku zasshi [Yakushigaku Zasshi] 2004; Vol. 39 (2), pp. 315-20.

نوع المنشور: English Abstract; Historical Article; Journal Article

بيانات الدورية: Publisher: Nihon Yakushi Gakkai Country of Publication: Japan NLM ID: 1267223 Publication Model: Print Cited Medium: Print ISSN: 0285-2314 (Print) Linking ISSN: 02852314 NLM ISO Abbreviation: Yakushigaku Zasshi

مواضيع طبية MeSH: Moths*, Camphor/*history , Insect Repellents/*history, Animals ; Camphor/standards ; History, 19th Century ; History, 20th Century ; Insect Repellents/standards ; Japan ; Marketing/history ; Quality Control

مستخلص: In the Meiji Era, the concepts of consumers did not exist; however, customers were certainly valued at that time based on the policy that "the customer is always right". Customers were always considered as guests, and there were no conflicting matters with manufacturers. The sales agency for Fujisawa camphor, Fujisawa Company, took up a positive attitude towards customer services. First, the company excluded imitation products in order to protect customers from poor quality, and second, the company released data regarding camphor comparisons and effects with other insecticides. At that time, they seemed to fear being talked about in terms of the mistaken use of camphor. The company commissioned a public research laboratory to study the interaction of camphor and precious metals, and made an appeal to customers for the truth.